BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC MAXIMO

    MDR report key: 1013425 · Received March 10, 2008

    Report

    Report Number
    6000094-2008-00080
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    October 24, 2007
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE, DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: PRELIMINARY TESTING REVEALED A HIGH CURRENT DRAIN CONDITION THAT RESULTED IN EARLY BATTERY DEPLETION AND THE REPORTED NO TELEMETRY AND NO OUTPUT CONDITIONS. FURTHER TESTING REVEALED THAT THE HIGH CURRENT DRAIN CONDITION WAS CAUSED BY A LEAKY CAPACITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC MAXIMO IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. 7304 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention