Dear Madam, Re: Regulation 28 report to prevent future deaths following the inquest touching upon the death of Mr Geoffrey Duke am writing in response to your Regulation 28 Report dated 30th May 2019 following the inquest touching upon the death of Mr Geofirey Duke. understand that during the inquest you identified concems arising from the absence of a referral process for patients who have undergone pacemaker' surgery who become unwell: It was identified that there was no referral to a cardiologist which led to a failure to identify that Mr Duke had become unwell due to an infection associated with a pacemaker insertion: would like to begin by offering an assurance that the Trust has taken steps to address the issues that you have identified, to ensure that there are mechanisms in place to prevent this occurring in the future. The Trust has implemented the following actions to ensure appropriate identification, diagnosis and referral to a cardiology speclalist for patients who "have suspected infection following a pacemaker insertion: can confirm that the enclosed (appendix 1) Cardiac Implantable Electronic Device Lead Infection Microbiology Hospital Guideline has been developed by the Antimicrobial Pharacist;, Cardiology Consultants and Microbiology Consultants. The document provides guidance on the detection_and treatment of Subacute Bacterial Endocarditis (SBE) related to cardiac rhythm devices. This is now subject to the Trust's governance process to formally sign the' guidance off. Once formally signed off , this guidance will be linked to the Trust's existing guidance for Pyrexia of Unknown Origin (PUO) as guidance for patients presenting with pyrexia (temperature) of unknown origin with a cardiac rhythm device in place. The final draft and final signoff in conjunction with a communication plan will be complete by 30th September 2019. Once sign off has been completed, the guidelines will be accessible to all staff through the Trust's intranet (called 'Flo') In addition; the Divisional Medical Director and Divisional Nursing Director will ensure that this information is disseminated to all the Clinical Smoklngg not permitted anywhere In ttebu Id nos and grounds of Derby Teactlng Hospltals For advice and support Chaic: John Rivers CBE DL aabout gMlng up smoklng please call freephone 0300027.4332. Chlet Executive: Gavln Boyle

WHS University Hospitals of Derby and Burton Directors within each of the Trusts divisions, and tabled at their medical meelinigEowdatanleat: staft: The development of this guideline supports the previous learning board shared with all Doctors in theDepartment of Medicine and the discussion at the Acute Medicine Mortality meeting in_ 2019, In_raising awareness with the relevant teams: For ease have also enclosed further copy of the learning board (appendix 2), Statement of (appendix 3) and SI report (appendix 4) to confirm the that the Trust is taking: Thiswillbe further supported at the Trust-wide Quality Summit on 26 September 2019 where with discuss this case and the learning that has been undertaken: It is hoped that aspecis oi the summit will be captured on videos and podcasts that will be available on Flo. Finally D wll also highlight-this learning within his monthly 'Patient Safety Brier; newsletter (August 2019) that is sent t all staff to further highlight the guidelines and the learning following this case. Conclusions The Trust has shared the learning from the inquest with the department of medicine to raise awareness _ This has been supported by & review 0f the guidance available to clinicians, within theOrganisation , relating to the identification and diagnosis of infection associated 'with cardiac rhythm device Following this review guidance has been developed and will be linked to the guidance relating to pyrexia of unknown origin: trust that you will be: satisfied that these changes have addressed the issues that you identified The Trust would very much welcome your feedback on changes that have been made to strengthen the care and management of patients with infection associated with cardiac rhythm devices: Please do not hesitate to let me know ifyou require any further information from the Trust

Partnes Salaried GPs Daruin Medical Practice e Our Ref: GYIACG 2019 PRIVATE AND CONFIDENTIAL SIGNIFICANT EVENI REPORT ANDACTION RE; Geoffrey Dyke DOB 27/4/1960 DOD 20/1212017 Late of Geoffrey Duke, a patient registered at this practice died in the Royal Stoke Hospital on 20 December 2017 This followed prolonged period of illness, during which it was unclear quite what was wrong with him_ Eventually, and unfortunately too late to prevent his demise, this was found t0 be as a result of infection arising from his pacemaker leads. This is seemingly an extremely unusual occurrence and was not thus recognised in several hospital admissions that had taken place prior to this final admission to hospital in Stoke_ As the GP who was responsible for seeing Mr Duke during most of his visits to the surgery ahead of his death, have been tasked to write this report, advocated by the coroner at his inquest, given that it was felt there needs to be a structured plan to consider this possibility, should there be further future instance thereof in any other individual, The clinicians at Darwin Medical Practice have met discussed in depth this case on Thursday 20 June 2019,as part of our regular Clinical Governance Meeting: The practice shared the information from HM Coroner looked back, in detail, through Mr Duke's medical record: It was agreed that this was an extremely unusual occurrence: It was agreed that the clinicians concered in Primary Care had made all appropriate steps to try elucidate However during his attendances at the surgery, there could be seen no way that this could have been picked up earlier within Primary Care. Mr Duke had attended on a number of occasions with relatively non-specific symptoms of malaise, with the only finding being of raised inflammatory markers; rightly this had been noted and documented and was being addressed and followed up. In fact; at the last time he was seen at the surgery _ he had improved in himself, as indeed had these clinical markers. It was noted that he was concurrently having hospital admissions and attendances. Given the rareness and the unexpected nature of the eventual outcome, the learning from this in Primary Care was that this ishow perceived as a possibility, where it may not have been considered before; the cause for Mr Duke'g malaise. it was felt the remit for the final diagnosis lay probably more within Secondary Care, but that thefessoh to be learned from this was that situations, even as unusual as this, are possible and should be considered ih any future similar scenario. Sigr DR GEORGE YOUNG All orrespondence t0. Branch surgeries: SL Ched s Health Centre; Burntwood Health Centre_ Chasetown Madlcal Centre; Dimbles Lane; Uchfield, Hudson Drive , Burnlwood, 29-31 Hlch Street, Burntwood, Staffordshlrc, WS13 7HT . Staflordshire; WS7 OEW. Staffordshire; WS? 3xE- Telephone: 01543 412980 Telephone: 01543 692654 or Telephone; 01543 671705 darwinmedicalpractice co.uk darwinmedical practice@nhs.net July any and and and

Dear Mrs Jones, Inquest touching the death of Mr Geoffrey Duke Responge to Regulation 28 Report to prevent future deaths write in response to the Regulation 28 Report made by you following the Inquest into the death of Mr Duke, which concluded on 14
2019. University Hospitals Birmingham NHS Foundation Trust (the Trust) has carefully considered the concems raised within report to prevent future deaths. Before address the specific concern You raise, would like to provide some detail as to the number of pacemakers placed within our Trust and the outcome of an audit that has been undertaken which includes the incidence of pacemaker related infection.
1. Review of pacemaker complications for both new Implants and upgrades The Incidence of pacemaker related endocarditis is low in comparison to other systemic infections. Most recent data suggests an incidence of approximately 4.5 cases per 1,000 pacemaker implants, giving an incident of 0.45%. The infection rate following a pacemaker change has an incidence of 1% within the first year. There were 1474 new implantslupgradesl device changes undertaken by our Trust during the last financial year: Infection is recognised complication of these procedures: Most recent audits of new implants undertaken in the Trust show an infection rate of 0% at 3 months on our QEHB site in 2018 and 0.65% at our Heartlands, Good Hope and Solihull sites in 2015. There Is ongoing audit however based on the evidence we have, we have not noticed any increase in reporting of infection post procedure. International published data (see reference below) Chair: Rt Hon Jacqui Smith Chlef Executive: Dr Davld Rosser for May your

suggests infection rates of 0.5-0.8% for new implants and 1-4% for device revisions (generator changes, upgrades or lead replacements): 2 Treatment provided to Mr Duke Mr Duke had a dual chamber pacemaker ftted in 2007 for complete heart block: Most devices require a battery change at around 5 to 7 years depending on use_ Mr Duke underwent a box change on 15 June 2016 which also included a change of the atrial lead as the impedance had dropped significantly: There were no complications noted following the change in June 2016. Mr Duke attended our ambulatory care clinic on 6 February 2017 where he was assessed by Consultant Physician: His presentation was in keeping with diagnosis f community acquired pneumonia for which he received antibiotics. Blood cultures were taken which were negative at this time, which would have been against the diagnosis of a pacemaker related endocarditis. Mr Duke was asked to return on 8 February when he was noted to be improving: We did not see Mr Duke again:
3. Cardiology referral for unwell patlents who have undergone pacemaker procedure We have an embedded referral process to our cardiology team on each of our sites for patients who present with suspected acute cardiac problems. This consists of a daily Consultant Cardiologist ward round at the Queen Elizabeth Hospital and Consultant of the week available for consultation at Heartlands, Good Hope and Solihull Hospitals. Our data shows that there are on average 15 ~ 20 referrals per to the cardiolgy team on each of our sites (60 80 referrals per day across our Trust) of patients with suspected acute cardiac problems; We are satisfied that our cardiology referral process works effectively across all our sites which can be evidence by the number of referrals to the cardiology team per day: We do know that device related endocarditis is a rare and often covert infection: There is no national algorithm available to assist in the diagnosis of pacemaker related endocarditis and no evidence base to design a specific algorithm. It is recognised , nationally that awareness of device related endocarditis amongst physicians is an issue and that in the absence of clear signs of pacemaker pocket infection, a diagnosis of pacemaker related endocarditis is often delayed as referenced in the Guidelines for the diagnosis, prevention and management of implantable cardiac electronic device infection Report ot joint Working Party project on behalf of the British Society for Antimicrobial Chemotherapy (BSAC, host organization) , British Heart Rhythm Society (BHRS), British Cardiovascular Society (BCS), British Heart Valve Society (BHVS) &nd British Society for Echocardiography (BSE) J Antimicrob Chemother 2014)' day

Action Plan Having reviewed our referral process to our cardiology teams, we are satisfed that we have in place an effective referral process however as a result of your report we have undertaken & review 0f our endocarditis guidelines to ensure they are robust and we are assured that our guidelines are comprehensive and include specific reference to device related infection and endocarditis and therefore do not require any amendment; Our review of the literature suggests ,that one of the key issues in the delay in diagnosing device related endocarditis is a lack of awareness amongst both patients and acute physicians. To raise awareness of pacemaker related endocarditis amongst our acute physicians, we are undertaking a programme of education which be provided via our grand round t0 alert our staff to the possibility % pacemaker endocarditis. This will be undertaken in the next academic term (September December 2019). We will also be sending out a 'Lesson of the Month' which is an email which goes out to all staff with the aim to raise awareness of the signs and symptoms of pacemaker related endocarditis This will be circulated within the next 4 weeks. We have also reviewed the patient information leaflets which are provided to all patients following pacemaker insertion, The leaflets already contain infommation oe symptoms which might represent possible infection and provide detailedf who the patient should contact if they_are concerned: Whilst we are satisfied that the information leaflets contain sufficient information for patients, we will be; updating them t0 include additional instructions where patients have symptoms of possible infection; in particular the leaflet will indicate that If the patient has & fever ind temperature above 38 degrees Celsius, then they should a) seek medical atteation and b) inform their treating clinician that they have pacemaker and that device related endocarditis should be considered, Our aim is to update the leaflets by the beginning of November 2019. would like to assure you that the concems raised within the Regulation 28 Report have been taken extremely seriously which hope is demonstrated by the steps we have taken in reviewing our processes and guidelines and which We will be taken to raise awareness of device related infection.