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Device Related Endocartitis And Hearing Loss Caused By Failing To Obtain Properly Informed Consent


Mrs S had a pacemaker fitted in 1990 when she was 30 years old. The device was sited in the deep pocket of her breast tissue towards her right armpit. Mrs S had a scar under her right armpit which was not visible and Mrs S had her device specifically sited at this location as she did not want a visible and palpable scar present. Since the original pacemaker implantation, Mrs S had subsequent replacement procedures.

My client then relocated to London in 2017 and her care was transferred to a Central London Hospital NHS Trust.

Around September 2017, Mrs S attended a Pacemaker Clinic, where she was reviewed and was informed that her pacemaker was reaching end of life and she would require a replacement procedure.

In October 2017, Mrs S attended a pre-assessment clinic at the Defendant Hospital and during this assessment, Mrs S informed the nurse that she wanted her pacemaker device placed back in its original position and wanted the device to be extracted from the scar by her right armpit. The procedure was scheduled to take place in November 2017.

On the day of the procedure, Mrs S spoke to the anaesthetist and requested to speak to the surgeon as it was very important to her that her existing scar site was used and for her pacemaker device not to be palpable – this was conveyed to the anaesthetist and she was informed that she would be seen by the surgeon prior to the procedure taking place. Mrs S was quickly consented (for an entirely different procedure), sedated and was taken to theatre but was not given the opportunity to speak to a surgeon beforehand.

Mrs S was discharged the same day. On the following day, Mrs S changed her dressing and noticed two new incision scars on the top of her right breast. The pacemaker device was palpable and the profile of the device was visible through her skin which made her extremely upset.

A complaint was made by Mrs S to the Defendant Trust and Mrs S was invited to attend hospital again so that her pacemaker could be re-positioned.

Mrs S underwent her second procedure in December 2017 and she was happy with the position of the pacemaker. Around March 2018, Mrs S was admitted to the Defendant hospital following a 6 week history of pyrexia, night sweats, nausea and weight loss.

Investigations revealed that Mrs S was suffering from sepsis and had device related endocarditis. The device had to be removed and Mrs S was given a prolonged course of antibiotic treatment which required the insertion of a PICC line causing her hearing loss. Mrs S also suffered from psychological injuries as a result of the negligent event.

How Hodge Jones & Allen helped

Our medical negligence team were instructed by Mrs S to recover damages for the injuries that were caused by the Defendant Trust.

We helped Mrs S by sending a Letter of Claim to the Defendant Trust, however liability was denied.

Court proceedings were thereafter issued and it was Mrs S’ case that the Defendant Trust was negligent in:

  • Failing to obtain informed consent for her procedure;
  • Failing to provide Mrs S the opportunity to discuss her procedure with the surgeon prior to undergoing it;
  • Failing to note Mrs S’ repeated requests to site the device in its original site using the same scar site
  • Failing to make Mrs S aware of all the material risks of the procedure including the risk of a new incision and change in the location of the device
  • Failing to ensure that Mrs S understood all aspects of the procedure and its risks before she could give informed consent.

The Defendant Trust provided their defence and continued to deny liability on the basis that warning Mrs S of a new incision and a change in the location of the pacemaker device was not a material risk, that she should have been aware of the risks from her previous replacement procedures and that it was not possible to use the existing scar site to extract Mrs S’ device (this was not the case as during her second procedure, Mrs S’ device was put back in the same position using her original scar site).

Procedures for consenting to medical treatment

After protracted negotiations, Hodge Jones & Allen settled Mrs S’s claim.

This case is an example of where there were deficiencies in the consenting procedure and illustrates the importance of advising and disclosing on all risks connected to a procedure as per the ruling in the Supreme Court case of Montgomery v Lanarkshire Health Board [2015] UKSC 11. The crucial judgement is found at paragraph 87;

‘The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.’

In cases involving informed consent a more patient-focused and holistic approach should be adopted. The case of Montgomery is a shift towards an individualised assessment and makes it clear that doctors are under a duty to understand the particular and personal concerns of their patients and that the patient plays a pivotal role in decision making.

Mrs S had emphasised the importance of ensuring that her device was not palpable and that she did not want any new scarring but her wishes were not heeded to. Further, in Mrs S’ case, she was not warned of the material risks of the procedure as she was asked to consent to a procedure that she was not going to undergo.

It is disappointing that Mrs S was not warned of all the material risks of the procedure, had Mrs S been warned of the risk of the two new scars and a change in location of device, she would have avoided her injuries.

Damages awarded: £12,500


If you’re seeking legal advice relating to medical negligence due to lack of consent please call our highly experienced medical negligence experts on 0330 822 3451 to talk through your situation with us. Alternatively, you can request a call back online.