Safety issues reported with Medtronic Pacemakers

In January 2019, Medtronic, a multinational medical technology company and producer of the devices, released an ‘Urgent Field Safety Notice’  alerting treating clinicians to the potential problem. Medtronic admit that over 155,000 devices worldwide may be affected. 

In the Field Safety Notice (FSN), Medtronic state that they have launched a, “voluntary recall and distribution suspension affecting a subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta™,Versa™, Sensia™, Relia™, Attesta™, Sphera™, and Vitatron™ A, E, G, Q series”. 

Medtronic advise that some of the above devices are affected by a problem that, in certain circumstances, can lead to a circuit error which may result in the device withholding pacing. As of 4 January 2019, two patients had reported a total of four occasions on which pacing had paused apparently due to this circuit error. 

Medtronic do, however, note that not all devices carrying the relevant brand names are affected by the issue. In particular, Medtronic suggest that only those devices which were produced following a design change and which were distributed between 10 March 2017 and 7 January 2019 will be affected. 

Patients are likely to have already been contacted by their treating consultants if their device is affected by the FSN.

Medtronic advise treating clinicians first to change the device settings and monitor affected patients. However, they accept that some patients may not tolerate the altered devices settings and that, in those circumstances, replacement of the device may be necessary. 

Gene Matthews, partner in the consumer law & product safety department at Leigh Day commented:

“It is difficult to imagine a device where patients will expect a greater levels of safety than a pacemaker. Any heart device that fails will inherently expose patients to the gravest dangers. Medtronic refer to these in their Field Safety Notice using the clinical terms of “patient mortality risk”. 

“While Medtronic suggest a ‘work around’ solution, it is clear that some affected patients may have no option but to have the device surgically replaced. The law is clear that patients who undergo the pre-emptive replacement of a potentially faulty device on which life might depend are entitled to compensation. 

“Patients will be reassured to some extent that Medtronic have implemented a voluntary recall and plan for affected patients. However, the extent to which appropriate testing was carried out before the design change referred to in the Field Safety Notice was implemented, and the fact that it took almost two years for the potential fault to be detected must be questioned.”

If you are concerned that you or a family member is affected by the FSN and has not already been contacted by your treating clinician we recommend that you contact your GP or treating hospital as soon as possible. 

If you would like to discuss your legal options please contact Leigh Day on 0207 650 1089 for an initial conversation.