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University Hospitals Birmingham NHS Foundation Trust

P-001484 · Statement · Decision date: 30 August 2022 · View University Hospitals Birmingham NHS Foundation Trust scorecard
Complaint (AI summary)
Mrs D complained the Trust's response was inaccurate, believing her husband's ICD malfunctioned and delivered excessive shocks, potentially causing his death.
Outcome (AI summary)
The ombudsman found no indication the Trust's explanation was wrong, concluding available evidence supported that the ICD did not malfunction.

Full decision details

The Complaint

3. Mrs D complains about the Trust’s response to her complaint. Specifically, she disagrees with its conclusions that her husband’s ICD did not malfunction on the day he died. Because he seemed quite well beforehand, Mrs D is concerned the ICD ‘glitched’ and shocked him more than it should have.

4. She is concerned her husband’s death may have been avoidable if not for the ICD malfunction. She wants to know if the Trust’s response and explanation is accurate.

Background

5. Mrs D’s husband, Mr D, had a heart attack in 2019 that left him with a damaged heart. He was transferred from his local hospital (in a different part of the country) to the Trust for further treatment. In July 2019 the Trust fitted an ICD. This is a small device placed under the skin that monitors the heartbeat and sends electrical pulses, called shocks, to correct it.

6. On 9 December 2019, Mr D’s ICD delivered a series of shocks because it detected his heart was beating abnormally. Mrs D tells us the shocks were strong enough to knock her husband off his feet and cause tremendous pain, so they called for an ambulance. In between the shocks, Mr D was able to go upstairs, go to the bathroom, and get dressed.

7. The paramedics decided Mr D needed to go to hospital. He was able to walk to the ambulance before receiving more shocks. Sadly, his heart stopped, and he died before the paramedics could take him to hospital.

8. Mr D’s death was referred to the Coroner. Data was manually downloaded from the ICD on 12 December. It is unclear who did this, but it appears this was done at the local hospital to assist with the Coroner’s post-mortem. The Coroner concluded the ICD fired shocks appropriately, and Mr D died as a result of his damaged heart.

9. Mrs D complained to the Trust about her husband’s death, but the Trust could not say anything new about the ICD because it had no data from it. The ICD was programmed to send data at night, and sadly Mr D died before the ICD could transmit that day’s data.

10. The Trust initially thought the data, downloaded from the device on 12 December, had been deleted, but in late 2021 it received some partial data from the Coroner. The Trust reviewed the data and explained it to Mrs D. She complained to us about this explanation.

Findings

13. Before we decide if we should conduct a detailed investigation of a complaint, we look at whether there are signs the organisation has got something wrong. We do this by comparing what should have happened with what did happen. We have done this and have not found any indications that something has gone wrong.

14. Our Principles say organisations should provide honest, evidence-based explanations when they respond to a complaint.

15. In its explanation, the Trust said the ICD was programmed to deliver shocks when Mr D’s heart was out of rhythm and beating dangerously fast. It explained the partial data showed the ICD gave shocks throughout the morning, but there were not detailed readouts for all the shocks. The initial shocks worked, but further episodes occurred.

16. The Trust explained that although the initial shocks worked, Mr D’s heart continued to beat abnormally, despite the ICD giving him further shocks. The Trust found that although the ICD could not successfully prevent Mr D’s death, there was no evidence it malfunctioned.

17. We took clinical advice to help us understand what the ICD data showed. We then considered whether the Trust’s explanation was accurate.

18. The data shows us the ICD fired appropriate shocks as programmed when Mr D’s heart was beating very fast, or in an abnormal rhythm.

19. The initial shock was at around 7.56am. This seemed to work well in correcting the issue, and there were no further episodes until 8.53am. This matches up with Mrs D’s account, that her husband was relatively well after the first shock.

20. From 8.53am to 9.26am the ICD delivered 13 more shocks. Some of these were only a minute apart. There was a period of seven minutes when no shock was given, and this correlates with the period where Mrs D says her husband had shocks in quick succession but was then well enough to get dressed and head down to the ambulance waiting outside.

21. The data shows that despite these 13 shocks, Mr D’s abnormal heart rate and rhythm persisted. As time went on, Mr D’s heart was sadly becoming more damaged, and it was becoming harder for the ICD to correct the persisting issues.

22. We have seen no evidence the ICD malfunctioned or sent a shock when Mr D did not need it. Rather, the device functioned as it was programmed to, but this was sadly not enough to prevent Mr D’s death.

23. We therefore consider the Trust’s explanation of what happened to Mr D, and it’s view that the device did not malfunction, is supported by the available evidence and in line with our Principles.

24. We understand why Mrs D has concerns about her husband’s death as it was unexpected and sudden. It is clear these were very upsetting events. We hope our decision helps Mrs D understand what happened, and we thank her taking the time to raise her concerns with us.

Our Decision

1. We have carefully considered Mrs D’s concerns about the Trust’s response to her complaint, and its explanation of what happened with her husband’s implantable cardioverter defibrillator (ICD) on the day he died.

2. We have decided the Trust’s explanation that the ICD did not malfunction is supported by the available evidence and there are no indications its response was wrong. We recognise this matter is, understandably, concerning for Mrs D. We hope the explanation of our decision in this statement helps to resolve her concerns.

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