BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES

    MDR report key: 3152069 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01181
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    NVY
    PMA / PMN Number
    P030036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. CONCOMITANT PRODUCTS: PRODUCT ID 4574 IMPLANTABLE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR DUE TO POSSIBLE PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. DURING THE REPLACEMENT PROCEDURE, THE PHYSICIAN FOUND THAT THE ATRIAL LEAD THRESHOLD HAD INCREASED. A NEW LEAD WAS ATTEMPTED TO BE IMPLANTED, BUT FAILED. THAT LEAD WAS NOT USED AND THE EXISTING LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252925 DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MEDTRONIC 3830

    Patients

    Seq Age Sex Outcome Treatment
    1 7285 IMPLANTABLE CARDIOVERTER IMPLANTED: 2009-02-