Source: Medicines & Healthcare products & Regulatory Agency (MHRA)
Summary
On the 13th of February 2019, MHRA issued a Medical Device Alert for Implantable Cardiac Pacemakers manufactured by Medtronic Inc. The alert is in regards to a subset of dual chamber pacemakers that may experience a loss of pacing therapy when programmed to a dual chamber mode with atrial-sensing.
Necessary Actions
All cardiologists and cardiac physiologists who manage patients implanted with pacemakers
- Read the manufacturer’s Field Safety Notice (FSN)
- Identify all affected devices supplied to your hospital between March 2017 and January 2019 using the serial number look-up tool on Medtronic’s Product Performance website: http://wwwp.medtronic.com/productperformance. Additional support in identifying affected devices is available from Medtronic – see details in ‘Manufacturer contact’.
- Do not implant affected devices; quarantine them and contact Medtronic to arrange return.
- Identify all patients already implanted with an affected device and verify the programmed pacing mode for their pacemaker.
- Arrange an in-clinic assessment for all patients with a pacemaker programmed to a susceptible pacing mode (see FSN). Prioritise patients without an underlying escape rhythm to prevent syncope who should be seen as soon as possible and ideally within 1 month. Be aware that if these patients are also in atrial fibrillation, this increases the risk of a circuit error occurring.
- Follow the recommendations for pacemaker reprogramming included in the FSN.
- Consider pacemaker replacement for patients without an underlying ventricular escape rhythm who are unable to tolerate a non-susceptible pacing mode, taking account of their individual procedure related risk.
Report adverse events involving these devices either directly or through your local incident reporting system to your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to the manufacturer.