BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUPERIOR VENA CAVA LEAD

    MDR report key: 5776 · Received July 1, 1993

    Report

    Report Number
    5776
    Event Type
    Death
    Date Received
    July 1, 1993
    Date of Event
    May 29, 1993
    Report Date
    June 8, 1993
    Manufacturer
    CARDIAC PACEMAKERS, INC. (DIVISION OF ELI LILY)
    Product Code
    LWT
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH AICD EXPIRED ON 5/29/93. DEVICE REMOVED AND INTERROGATED. RESULTS INDICATE THAT DEVICE FIRED THIRTEEN (13) TIMES. LEAD IMPEDENCE OF LAST FIRING MEASURED GREATER THAN 250 OHMS. REVIEW OF CHEST X-RAY OF 5/1/92 SHOWS SMALL AREA OF RADIOLUCENCY AT THE SUBCLAVIAN, FIRST RIB JUNCTIONDEVICE 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: ELECTRICAL TESTS PERFORMED. RESULTS OF EVALUATION: COMPONENT FAILURE. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Implant SUPERIOR VENA CAVA LEAD LWT CARDIAC PACEMAKERS, INC. (DIVISION OF ELI LILY) C10 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death