For patients
If you are a UK patient with an implantable pacemaker or implantable cardioverter defibrillator (ICD) and have concerns about:
- whether your implant is working correctly
- your implant being affected by a manufacturer's safety advisory notice
- the effects of your occupational environment on your pacemaker
- possible interference effects from general electrical equipment, mobile phones or rooftop aerial masts
- shopping where electronic article surveillance anti-theft systems exist
- suitability to travel and airport security metal detectors
- forthcoming general surgery and how your pacemaker or ICD might be affected then you should seek advice from the hospital pacemaker/ICD follow-up clinic you normally attend.
General booklets about implantable pacemakers or ICDs are available from the British Heart Foundation - Heart Information Line 08450 70 80 70. Or write to:
British Heart Foundation
14 Fitzhardinge Street
London W1H 6DH
Tel: 020 7935 0185
For clinicians
The MHRA encourages cardiologists and physiologists, who manage patients with pacemakers and ICDs, to report adverse incidents where deterioration of the device has led to patient harm - or could have done so.
Examples of adverse incidents associated with implantable pacemakers, ICDs and accessories include:
- premature battery depletion (taking into consideration programmed settings and usage)
- unclear or conflicting battery status/longevity indicators
- lack of battery status indicators within manufacturer specified periods
- unexpected decrease/increase in lead impedance
- unexpected programming problems
- inappropriate delivery of therapy
- non-delivery of therapy
- unexplained or non-reversible permanent backup mode pacing
- device/programmer telemetry failure (inability to reprogramme)
- abnormal programmer/device behaviour following software upgrades.
In consultation with clinicians, the MHRA has developed a dedicated adverse incident report form for pacemakers and ICDs.
Reports can be made online via the MHRA website (preferred), alternatively a dedicated malfunction report form can be downloaded from the website and reports e-mailed/faxed to the MHRA Adverse Incident Centre.
Full information and guidance on reporting Adverse Incidents is published annually in a MHRA Device Bulletin titled 'Reporting Adverse Incidents and Disseminating Medical Device Alerts'.
For manufacturers
Manufacturers have a legal obligation to report direct to the MHRA any occurrence (within the UK) where a patient has died, or has been harmed, as a result of an adverse incident occurring with a pacemaker or ICD - or where there was potential for death or harm to occur.
Manufacturers should refer to the vigilance system for specific guidance on requirements to report adverse incidents. They should also consult the Active Implantable Medical Device Directive.
The MHRA has developed a Manufacturer Online Reporting Environment (MORE) to facilitate incident reporting by manufacturers.
