BEUDAMED
    FDA Adverse Event Summary report: N

    REFLEX DDD

    MDR report key: 323 · Received February 19, 1992

    Report

    Report Number
    323
    Date Received
    February 19, 1992
    Date of Event
    January 20, 1992
    Report Date
    January 24, 1992
    Manufacturer
    TELECTRONICS
    Product Code
    DSZ
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    BATTERY STARTED FAILING AFTER 6 YEARS. LENGTH OF LIFE NOT CONSIDERED EARLY FOR THIS PRODUCTDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: EARLY EOL, RRT INDICATOR - END OF LIFE. CONCLUSION: DEVICE DISCARDED - UNABLE TO FOLLOW-UP. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX DDD Implant DSZ TELECTRONICS 8224

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Invalid Data