Safety Warning Over Medtronic Insync III Pacemaker

Nearly 6,000 Heart Patients Potentially Affected By Faulty Devices

16.12.2015

Oliver Wicks, Press Officer | 0114 274 4649

Product liability experts have urged patients fitted with pacemakers to seek medical advice after a manufacturer issued a safety warning over one of their devices. 

The Medicines and Health Care Products Regulatory Agency have issued a medical safety alert, warning of a potentially life-threatening electrical fault identified in certain models of the Medtronic Insync III Pacemaker. Full details of the affected models are available here: https://www.gov.uk/drug-device-alerts/cardiac-resynchronization-therapy-pacing-crt-p-risk-of-loss-of-pacing-therapy 

The warning identifies that some of the devices may develop unexpectedly high and variable battery impedances, which can cause the pacemaker to become ineffective. The battery failures have been associated with medical problems including difficulty breathing, complete heart block, weakness and dizziness. Medtronic have received one report of a patient death which may have been contributed to by the fault. 

It is believed that nearly 6,000 potentially faulty devices have been supplied in the UK between June 2001 and October 2010, when this product was discontinued, and to date there have been two incidents associated with this problem reported within the UK. 

Mathew Newbould, a solicitor and product liability expert at law firm Irwin Mitchell urged patients who believe they may be affected by the product warning to seek urgent medical advice.

If you or a loved one has suffered due to a defective or faulty defibrillator, our expert personal injury claims team could help you claim compensation. View our Faulty Defibrillator Claims page for more information.



Expert Opinion
“It is deeply concerning that there are 6,000 potentially faulty pacemakers in circulation.

“Over recent years we have seen multiple similar product recalls concerning faulty cardiovascular devices, which raise serious questions about whether more needs to be done to ensure such devices are fit for use before they are put into circulation.

"This safety warning comes after landmark ruling in the European Court of Justice (ECJ) last year in the case of Boston Scientific Medizintechnik GmbH v AOK Sachsen-Anhalt - Die Gesundheitskasse (C-503/13) and Betriebskrankenkasse RWE (C-504/13), which also concerned a faulty pacemaker manufactured by Boston Scientific, which had to be replaced following a charging issue.

"The Court highlighted that the safety requirements associated with products with ‘abnormal potential for damage’ should be particularly high, and because of that, where a patient is injured by a product which is within a class of products known to have a potential defect, that patient is entitled to assume that his or her own product was defective without the need to prove it specifically.

“Ultimately, these are life-saving devices and any fault can cost lives. The importance of eradicating manufacturing and design error is reflected in the Court’s approach.

"In this case Medtronic have acted responsibly in notifying those concerned of the problem, but standards must improve in the manufacture and design of this sort of medical device generally."
Matthew Newbould, Solicitor