Made to go through the AMD with a pacemaker

[earth-bound]

Eaglestar,

Sorry that your relative was affected by this issue, for someone else it could be potentially life threatening. I asume that this matter is known to his cardiologist who will be taking the appropriate steps together with medical devices specialists to ensure that the device is functioning correctly.

Pacemakers are programmed using electromagnetic induction. Users are advised not to wear magnetic fasteners on their blouses never mind going through a metal detector!

As this happened in the UK I expect that his UK cardiologist has reported this adverse incident to the Medical and Healthcare Products Regulatory Agency. They may perform an investigation alongside the pacemaker's manufacture, in this case I'd be very suprised if they didn't.

Make sure that this incident has been reported and ask for the hospital and the MHRA to copy you into all correspondence, it will add considerable weight to any valid claim.

The following is an extract from their website, www.mhra.gov

"
Reporting problems with implantable pacemakers and defibrillators

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Related information:

MHRA pages:

• Reporting adverse incidents

Featured publications:

• DB 2006(01) Reporting Adverse Incidents and Disseminating Medical Device Alerts

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: [phone]
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 (776Kb) for specific guidance on requirements to report adverse incidents. They should also consult the Active Implantable Medical Device Directive (external link).
The MHRA has developed a Manufacturer Online Reporting Environment (MORE) to facilitate incident reporting by manufacturers."

You can report it yourself but it's better done by the staff at his hospital who will (should?) be managing this serious untoward incident.

I hope he suffers no long term ill effects from this treatment and remember that aside from the issue compensation making a sensible and proper fuss could prevent this happening to someone else.