BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 3153476 · Received June 8, 2013

    Report

    Report Number
    9614453-2013-01144
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 27, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. PRODUCT EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE MET 86% OF EXPECTED LONGEVITY. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL. PRODUCT PERFORMANCE INFORMATION WAS RECEIVED, ANALYZED, AND BATTERY DEPLETION WAS INDICATED. THE TIME OF RECOMMENDED REPLACEMENT TIME IN SAVE TO DISK OCCURRED ON (B)(6) 2012 AS DEVICE WAS AT <(><<)>=2.62 VOLTS. CONCOMITANT PRODUCT: COMPETITOR IMPLANTABLE TACHY LEAD; 2187 COMPETITOR IMPLANTABLE PACING LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD EARLY ELECTIVE REPLACEMENT INDICATOR. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256937 N/A DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND C174AWK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 5076 IMPLANTABLE PACING LEAD