BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC DUAL CHAMBER PACEMAKER

    MDR report key: 6317 · Received August 16, 1993

    Report

    Report Number
    6317
    Event Type
    Injury
    Date Received
    August 16, 1993
    Date of Event
    June 28, 1993
    Report Date
    July 21, 1993
    Manufacturer
    MEDTRONIC
    Product Code
    DSZ
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT SUFFERED EPISODE OF SYNCOPE WITH PERIOD OF ASYSTOLESHOCKED; STABLEIZED; ADMITTED; PACEMAKER LEAD WIRE, BATTERY REPLACEDDEVICE 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: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: OTHER, BATTERY/PACK. CONCLUSION: INTERMITTENT FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC DUAL CHAMBER PACEMAKER Implant PACEMAKER DSZ MEDTRONIC 7070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other