BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 1329046 · Received February 28, 2009

    Report

    Report Number
    MW5010116
    Event Type
    Injury
    Date Received
    February 28, 2009
    Date of Event
    December 5, 2008
    Report Date
    February 27, 2009
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ROUTINE IN PERSON PACEMAKER TEST 2008. NO PACING SPIKES OR MAGNET RESPONSE OBSERVED. UNABLE TO INTERROGATE DEVICE. NO PACEMAKER FUNCTION WAS UNDERLYING ATRIAL FIBRILLATION WITH INTRINSIC VENTRICULAR RESPONSE; HOWEVER, SOME VENTRICULAR RATES AS LOW AS 30-40 BPM. ADVISED TO REPLACE PACEMAKER ASAP. DEVICE REPLACED - 2008. IN 2009- MEDTRONIC ANALYSIS REPORT FOUND LIFTED BOND WIRES ON THE HYBRID BOND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC KDR651 KAPPA 650 DXY MEDTRONIC INC. KDR651

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R