GEM® DR and Micro Jewel® II ICDs 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2004/045

CON008505

2004-09-09

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON008505

Extended charge times and inability to deliver therapy at battery voltages close to elective replacement indicator (eri) for a subset of the above devices. since 1999 medtronic has issued a series of advisory notices concerning the performance of some gem® dr and micro jewel® ii icds. medtronic's most recent advisory notice is appended to this alert and updates previous follow-up recommendations for affected gem® dr and micro jewel® ii icds. this most recent advisory notice followed receipt of reports in which appropriate therapy had not been delivered during cardiac arrhythmias. medtronic was concerned that these devices may not be capable of delivering adequate high voltage defibrillation therapy at or near the specified eri at 4.91v, or during the following period to end of life (eol), specified at 4.57v. the mhra is publishing this medical device alert to reiterate the recommendations made by medtronic, and to update and replace advice previously issued by the medical devices agency in ptn no. 80.

Note that the recommendations in this update supersede the advice given in Pacemaker Technical Note (PTN No. 80 issued by the Medical Devices Agency in October 1999. Identify patients affected by referring to the serial numbers listed in Appendix 2. Follow the detailed instructions given in Medtronic's Advisory Notice (see Appendix 1). Carry out the following actions for all affected patients (refer to list of serial numbers): battery voltage of 5.16V or less , charge time of 18 seconds or greater . Trust managers should ensure that measures to implement the actions specified above are planned and completed within the following SABS deadlines: ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS) Further information about SABS can be found at: www.info.doh.gov.uk/sar/cmopatie.nsf