BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 180140 · Received July 29, 1998

    Report

    Report Number
    180140
    Event Type
    Malfunction
    Date Received
    July 29, 1998
    Date of Event
    June 11, 1998
    Report Date
    July 27, 1998
    Manufacturer
    MEDTRONIC INC
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD PACEMAKER IMPLANTED ON 1/25/1995. ON A ROUTINE CHECKUP IT WAS NOTED THAT THERE WAS NO PACEMAKER ACTIVITY. SHE UNDERWENT A PACEMAKER BATTERY REPLACEMENT ON 6/11/1998. THE PHYSICIAN NOTED THAT THE GENERATOR HAD A FLAW WITH THE CONNECTOR AND WAS REPLACED WITHOUT INCIDENT. THE PT WAS DISCHARGED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC Implant PACEMAKER DXY MEDTRONIC INC 7940 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other