BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 1840210 · Received September 15, 2010

    Report

    Report Number
    MW5017473
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    MEDTRONIC
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT IMPLANTATION OF A PROPHYLACTIC DEFIBRILLATOR ON (B)(6) 2005. ON (B)(6) 2010, WHILE AT REST, HE EXPERIENCED 3 SHOCKS FROM HIS DEFIBRILLATOR. HIS DEFIBRILLATOR WAS IMMEDIATELY INTERROGATED, AND IT WAS FOUND THAT HE HAD INAPPROPRIATE SHOCKS DUE TO FAILURE OF HIS VENTRICULAR LEAD SENSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC DEFIBRILLATOR LEAD LWS MEDTRONIC 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR