Implantation of a non-rechargeable device
13. Ms E complains the SNS device the Trust implanted is effective, but it is not the rechargeable one she requested. She said the device she chose allows you to see the battery life and has a life span of around 20 years. She said the current implanted device has a battery life of around three to five years.
14. She considers the Trust should have implanted her chosen device considering she had multiple appointments with the colorectal nurse to discuss the devices and help her choose the best device for her. The Trust says it does not stock these devices due to the cost of each device. This means not all models of devices are readily available which is why it is unable to guarantee the type of device available on the day of surgery.
15. The Trust says all devices are equally as effective and safe in treating bowel dysfunction, so the result for the patient will be the same irrespective of the model of device it implants. The Trust says the implanted device had a very positive outcome for Ms E and improved her overall quality of life.
16. It said the device it fitted is the correct treatment for her condition. Our adviser says the Trust acted appropriately as they confirmed there is no guarantee patients will get their preferred model of a particular SNS device. They said there is no specific guidance to implant a specific brand or model of SNS device.
17. However, they said the Trust did not communicate appropriately to Ms E before the procedure as it should have told her she might or would not get the preferred device and give her the available option. Therefore, the Trust did not manage Ms E’s expectations for this before and during the consent process for the procedure.
18. We can see principle one of the seven principles of decision making and consent in the GMC guidance says all patients have the right to be involved in decisions about their treatment and care and be supported to make informed decisions.
19. Our adviser referred to principle two in the GMC guidance which says decision making is an ongoing process focussed on meaningful dialogue. It involves the exchange of relevant information specific to the individual.
20. Paragraph 8 of the GMC guidance says the exchange of information between doctor and patient is central to good decision making. It’s during this process you can find what is important to a patient, so you can identify the information they will need to make the decision.
21. Our adviser says paragraph 3.4 of RCS guidance says surgeons should listen to their patient and respect their views about their health. It says,
‘The options for treatment should be discussed in relation to the patient’s own wishes and values. Working in partnership with patients requires learning their views and expectations about their treatment and working together to inform patients of the options available for achieving the best outcome for them…’
22. Our adviser says even though the Trust thought the implanted device was equivalent to the one Ms E wanted, it did not sufficiently consider her views nor adequately explain preoperatively why the alternative device was the only one it could implant.
23. We also see no evidence the Trust told her about the only available device before she had the surgery. We could see Ms E had an appointment with the colorectal nurse on 18 August 2021. They said they were pleased to say Ms E had seen a significant improvement in her bowel symptoms.
24. They said if all agreed, the Trust would apply for funding, and if this is agreed it will add her to the waiting list for the procedure. This appointment was the only one we could see where the Trust discussed the different types of SNS devices and Ms E said she wanted to have the Medtonic re-chargeable device.
25. Ms E told us the Trust should have told her about the unavailability of the chosen device so she would know what it was implanting to know what to expect. From review of the above guidance and Ms E’s medical records, we consider the Trust did not appropriately communicate and manage her expectations by telling her she might not get the chosen device and give her the available option before her operation.
26. Therefore, it did not act line with the above GMC and RCS guidance and is an indication of failing. Our adviser says as the Trust did not make Ms E aware there was no guarantee she would not get the preferred device before the procedure she did not have the opportunity to make an informed decision as to whether she should go ahead with the surgery.
27. Ms E told us she does not know if she would have still consented to the available device had she known the preferred device was not available at the time. She said she might have still agreed to go ahead with the surgery as she needed the treatment due to being so ill because of her health condition.
28. In a recent letter to us Ms E said the issues with her bowel began in 2020 and escalated to the point where the Trust had to admit her. Some of her symptoms included vomiting stool and suffering a great deal of pain. She said she does not know what state of mind she would have been in at the time to know whether she would have consented to the alternative device.
29. We can see when she found out about the issue this would have caused her worry and distress wondering whether she should have gone ahead with the surgery had she known about the unavailability of the chosen device.
30. The Trust apologised it cannot give guarantee it will insert a particular device. The Trust says wherever possible it tries to accommodate a patient’s preference for the type of device, but it is not always possible. It says it discussed with the team to ensure it makes patients aware of this before surgery. It apologised it did not explain this to Ms E when it discussed the different devices before the surgery.
31. The Ombudsman’s Principles of Remedy say we would expect organisations to acknowledge mistakes and apologise for the impact these mistakes had. We would also expect organisations to take action to learn and improve from its mistakes. We do not consider the Trust’s response acknowledges the worry and distress of Ms E wondering whether she should have had the surgery.
32. We asked the Trust to reconsider its response and provide an updated version. The Trust has now acknowledged and apologised for the worry and distress it caused to Ms E. It provided further detail and steps to help prevent a similar thing happening again.
33. The doctor involved says they will ensure the device to be fitted is discussed during the consent process so all patients can make an informed choice as to whether they wish to proceed with the surgery or delay it.
34. The Trust says it shared Ms E’s complaint at the colorectal clinical governance meeting on 16 May 2023. It says this type of meeting is where consultants, nursing colleagues, and business teams meet each month to share learning and good practice so that departments can continue to learn and make improvements to the service they deliver.
35. We understand it was a very distressing and upsetting time for Ms E. Especially as both her and her son were very unwell at that time. We are satisfied the Trust has taken appropriate steps to remedy the complaint by acknowledging wrongdoing, apologising and improving its service. For this reason, we will not take further action.
Monitoring of device
36. Ms E says she cannot check the battery life of the implanted device. She says she does not have regular appointments for checking the battery life. She says she only had one appointment to check the device that stemmed from her complaining to the Trust.
37. The Trust says it assures Ms E will continue to undergo the standard checks for the current device she is already receiving. It said there are no indications she needs more intense checks. The Trust’s email of 27 November 2024 said its colorectal nurse specialist team (CNS) sees Ms E every six months and she has their direct contact details if worried between appointments.
38. We can see after the Trust implanted the SNS device, Ms E attended multiple appointments with the Trust’s colorectal surgery department, and bowel dysfunction clinic to review the effectiveness of the device between March 2022 to September 2024. Ms E attended an appointment on 30 March 2022 to activate the device.
39. On 6 June 2022 Ms E attended an appointment with the consultant colorectal surgeon who said they were delighted to see the great result following the insertion of the device. They said previously she was unable to open her bowels at all, and now she was opening her bowels mostly every or alternate days. It recorded Ms E described the effect as life changing.
40. It then said it would continue to keep her under review with its specialist bowel nurses. A colorectal nurse specialist saw Ms E three months later 15 September 2022. Again, she said she was happy with the function of the device. She reported pain at the battery side and that it protruded. The nurse specialist examined her and could not feel the battery through the skin.
41. They explained if they replaced the device with a rechargeable one this may result in loss of such good function. They suggested when the new rechargeable device, Medtronic X, is available this may be more suitable for her at the time of the battery change. Ms E agreed with this plan. They then said they would review her again in a year.
42. Ms E attended an appointment at the bowel dysfunction clinic with a colorectal nurse on 5 September 2023. They said her device was working well in controlling her bowel symptoms. Ms E was concerned she had a recent fall so the battery may have moved. The nurse checked the lead, battery and battery site for the device and considered all satisfactory.
43. The Trust said it would review Ms E again at the nurse led clinic in 12 months to monitor her progress, but she had their contact details should she have any questions. Ms E attended an appointment with the consultant colorectal surgeon a month later on 12 October 2023. They reviewed her and said the device was still having a good effect on her bowel movements. They discussed her concerns and the options about her prolapse of the rectum.
44. Ms E then attended further appointments within six months with the colorectal nurses at the bowel dysfunction clinic. They had no concerns on 7 March 2024 and said would keep her GP informed of any changes. On 13 March 2024 they said they were pleased to hear the device had still been working and controlling her bowel symptoms. They said they would review her in the nurse led clinic in 12 months.
45. Within a month Ms E attended a further appointment with the consultant colorectal surgeon on 22 April 2024 discussing symptoms of her rectal prolapse. It acknowledged the SNS device continued to give her some benefit. Ms E attended the bowel dysfunction clinic sooner within six months on 19 September 2024. The nurse recorded Ms E said the device was working well. However, she said she felt the Trust gave her the wrong stimulator.
46. They advised she has very good function with the current device. She was worried she would end up having a dead battery inside of her. They explained this would not be the case since they regularly monitor her to check the battery life. They said they would review her again in six months and checked she had the correct contact number for them.
47. From review of the above, we can see the Trust’s consultant and specialist nurses saw Ms E within three to 12 months of implanting the device. Our adviser said the Trust gave Ms E open access for her to speak to someone about the device if she had any concerns.
48. Our adviser referred to page seven of the European guidance for SNS devices which says the first SNS follow up appointment should be arranged at one to three months after implantation for stimulation programming or adjustments.
49. They said although this guidance is stated under information about SNS for faecal incontinence, it still applies to patients with constipation, like Ms E. This is consistent with the information at the beginning of the guidance which said during the last decade SNS devices have been used to treat faecal incontinence and constipation.
50. As mentioned above, Ms E attended her first appointment on 30 March 2022, and then 6 June 2022 to review the device. We consider the Trust acted in line with the European guidance for SNS devices for arranging the follow up appointment after the surgery.
51. Our adviser says there is no specific guidance for how often clinicians should review patients with the devices. They confirmed the frequency of appointments Ms E had with the colorectal department and bowel dysfunction clinic was appropriate.
52. After her appointment in June 2022, she had regular appointments from September 2022 to September 2024. Our adviser referred to paragraph 15 (a) and (b) of the GMP guidance which says it is the clinician’s decision to decide how often to arrange appointments to review patients as dictated by clinical need.
53. The GMP guidance says clinicians must provide a good standard of practice and care. If they assess, diagnose or treat patients, they must:
• Adequately assess the patient’s conditions, taking account their history…
• Promptly provide or arrange suitable advice, investigations or treatment where necessary.
54. Our adviser reviewed the appointments Ms E attended and said the Trust acted in line with the above GMP guidance. We consider although the specialist nurses saw Ms E regularly, it is the consultant colorectal surgeon who has overall supervision and oversees Ms E’s colorectal care.
55. This is supported by the consultant’s initial review of Ms E after implantation of the device in June 2022 when they said they would continue to keep Ms E under review with their specialist nurses. When Ms E reported pain at the battery site in September 2022 the nurse examined her. When she was worried about the battery life of the device in September 2024 the nurse continued to listen to any concerns and reassure her.
56. Overall, with no red flags raised about the device during appointments at the Trust and it gave her direct contact details if any health concerns or changes arose, we consider the Trust’s previous and current monitoring of Ms E’s device is in line with the European guidance for SNS devices and GMP guidance.
57. We have seen no indications of failings for this issue and shall not consider it further. We are pleased the device has been working well for Ms E’s bowel symptoms and improved her standard of health overall. We wish her all the best in her health going forwards.