Marquis VR 7230, Marquis DR 7274, InSync Marquis 7277 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2004/019

CON008561

2004-04-26

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON008561

Potential battery defect; possible rapid depletion, prevalence unknown. in september 2003 the mhra received a report from a uk hospital of a model 7274 marquis dr implantable cardioverter defibrillator (icd) that was unresponsive to programmer interrogation at a follow-up four months post-implant (i.E. device status could not be determined). the patient was unaware of any change. at one month post-implant this icd had been functioning normally. initial failure analysis by medtronic indicated the battery voltage to be 0v (zero volts), with no attributable fault in the icd's electronics. battery analysis revealed a defect due to damage incurred during manufacturing. subsequently, medtronic confirmed two similar non-uk incidents in which patients experienced localised tissue heating and pain. in may 2002 a battery in production was first identified with this defect. subsequently in october 2002 two additional batteries used in device production were found to have an identical defect. by march 2003 medtronic had implemented improved manufacturing techniques and quality control testing in order to limit this problem. review of the three explanted icds to date has now shown that some batteries, produced prior to completion of these manufacturing changes and which met original test specifications, may still have a potential to fail. if a defect is present, rapid battery depletion may take place without prior indication at a non-predictable time after implant, possibly occurring even within the advised three-month follow-up period. (this follow-up period is consistent with manufacturer device labelling). within a few hours there will be a complete loss of device function and patients will not receive therapy from the icd. it is also possible that, as the battery rapidly depletes, patients may experience localised pain and/or heat in the tissues surrounding the icd as energy is dissipated within the device. however, although examination of information available to date shows the frequency of occurrence for this problem to be low (1 in 10,000 worldwide), caution is warranted because of the impact that failure could have on the patient. current overall performance of this family of icds is comparable to other icds. approximately 31,000 potentially affected devices have been distributed worldwide, with 805 in the uk. affected batteries were not used in any other medtronic model of icd supplied to the uk. no other icd manufacturer uses this battery. the mhra will continue to monitor this problem through the adverse incident reporting system and will issue further advice as appropriate.

Clinicians are advised to: Identify and return to Medtronic any of the potentially affected devices not yet implanted (see the lists of affected serial numbers under 'Device' section). Ensure that patients implanted with potentially affected devices are followed up at intervals of no more than three months. Inform all patients to immediately contact their ICD centre if they experience: Persistent arrhythmias/resumption of symptoms which remain uncorrected by the ICD and/or Heating sensations or pain in body tissue surrounding the implant. For the MHRA recommended actions see above. DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM