Guidant implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds): Contak Renewal 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2005/041

CON1004088

2005-06-30

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON1004088

Recall due to component failure resulting in potential loss of cardioversion, defibrillation and reduced device longevity. guidant has informed mhra that all serial numbers of contak renewal® 4, contak renewal® 4 avt and renewal® rf devices are subject to a component failure that could result in limited available therapy, inappropriate therapy and a reduction in device longevity. as a precautionary measure, guidant has advised clinicians not to implant affected devices until further notice. guidant has confirmed that the magnetic switch in these devices has the potential to stick in the closed position, resulting in the inhibition of the device's ability to treat ventricular or atrial tachyarrhythmias. bradycardia pacing remains unaffected. an audible tone, emitted from the device warns patients and/or clinicians of this condition. this component failure will increase the device's battery consumption and significantly reduce device longevity. to date, guidant has distributed approximately 46,000 of these devices worldwide. there have been five reports, four confirmed and one unconfirmed, of component failure. the four incidents resulted in device replacement. in the uk, 670 devices have been distributed. there have been no reports of this component failure in the uk. the default setting for these devices is 'enable magnet use on'. for devices already implanted, guidant recommends reprogramming the device to 'enable magnet use off'. in 'enable magnet use off' mode: bradycardia pacing and treatment of tachyarrhythmias will continue as programmed if the magnetic switch becomes stuck in the closed position a magnet will no longer inhibit therapy temporary suspension of tachyarrhythmia therapy can be performed with a programmer the time between elective replacement indicators (eri) and end-of-life (eol) may be shortened.

See actions on page 2. Do not implant these devices until further notice from Guidant. Immediately segregate all unimplanted devices and return them to Guidant in accordance with their instructions. Review patients already implanted with these devices and verify device function using normal follow-up procedures. Instruct patients to go to a hospital Accident and Emergency department immediately or to contact their clinician if they hear bleep tones from their device. Consider programming device to 'Enable Magnet Use OFF'. Ensure that follow-up intervals are no greater than three months (as per instructions for use). Consider prophylactic explantation if the proposed programming option does not meet patient needs. Report all instances of device failure to MHRA and Guidant. Report explants to the National Pacing and ICD Database (see contacts). ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS) Trust managers should ensure that measures to implement the 'Actions' specified above are planned and completed in line with the following SABS deadlines. Further information about SABS can be found at: www.info.doh.gov.uk/sar/cmopatie.nsf