The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning the subcutaneous implantable defibrillator system, manufactured by Boston Scientific.

According to the manufacturer, a rare condition in which an internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. The fuse has been unintentionally activated once during an implant procedure and three times post-implant out of approximately 1,900 devices implanted worldwide. All three post-implant events occurred within one month of implant. The defibrillator may not be able to deliver therapy or communicate with the Q-TECH Model 2020 programmer, and may be unable to emit tones or otherwise respond to magnet application. No patient deaths or injuries have been reported as a result of this behavior.

A non-invasive, software-based mitigation (version 1.95.0) has been developed to protect the fuse from unintended activation. Local sales representative will install this new software on all Q-TECH Model 2020 programmers located at the hospital/clinic.

Furthermore, the manufacturer has the following recommendations for healthcare professionals:

• For patients whose device has been implanted for less than three months, it is recommended to schedule a follow-up visit as soon as possible within the next six weeks
• For patients whose device has been implanted for three months or more, ensure the next scheduled visit occurs within three months of the previous visit, as recommended in device labeling
• At the next follow-up visit, interrogate each patient's device using a programmer with version 1.95.0 software. Interrogation with an updated programmer will automatically add the new software to the implanted device.

According to the local supplier, the affected products were not distributed in Hong Kong.

For details, please refer to MHRA website
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON244550

If you are in possession of the product, please contact your supplier for necessary actions.

Posted on 12 March 2013