BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 5230 · Received April 28, 1993

    Report

    Report Number
    5230
    Event Type
    Malfunction
    Date Received
    April 28, 1993
    Date of Event
    April 14, 1993
    Report Date
    April 19, 1993
    Manufacturer
    MEDTRONIC
    Product Code
    DSZ
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ELECTIVE PACER BATTERY REPLACEMENT DUE TO BATTERY DEPLETION. PACEMAKER INTERMITTENTLY NOT CAPTURING. REPLACED BY PULSE GENERATOR. LEADS ALSO REPLACED. REPLACED LEADS WERE CAPPEDDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: EARLY EOL, RRT INDICATOR - END OF LIFE. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: OTHER. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC Implant PACEMAKER REPLACEMENT DSZ MEDTRONIC 8400

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other