BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIKOS GENERATOR

    MDR report key: 356 · Received March 27, 1992

    Report

    Report Number
    356
    Event Type
    Malfunction
    Date Received
    March 27, 1992
    Date of Event
    March 10, 1992
    Report Date
    March 16, 1992
    Manufacturer
    BIOTRONIK PACEMAKER
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    EXPLANTED A PIKOS (BIOTRONIK) GENERATOR. IMPLANTED A THERMOS PACEMAKER/LEAD MALFUNCTIONDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: INVALID DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIKOS GENERATOR Implant PACEMAKER DXY BIOTRONIK PACEMAKER THERMOS

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other