BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDIS PACES

    MDR report key: 3591 · Received December 29, 1992

    Report

    Report Number
    3591
    Event Type
    Malfunction
    Date Received
    December 29, 1992
    Date of Event
    September 8, 1992
    Report Date
    September 17, 1992
    Manufacturer
    CORDIS
    Product Code
    DSZ
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    IMPENDING BATTERY FAILURE - ELECTIVE PACEMAKER REPLACEMENTINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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 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: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDIS PACES Implant DSZ CORDIS 337-A N/I

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other