BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBI BONE GROWTH STIMULATOR IMPLANTABLE SPINAL FUSION STIMULA

    MDR report key: 8674 · Received August 29, 1994

    Report

    Report Number
    8674
    Event Type
    Injury
    Date Received
    August 29, 1994
    Report Date
    February 1, 1994
    Manufacturer
    EBI MEDICAL SYSTEMS, INC.
    Product Code
    LOE
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD LUMBAR FUSION WITH INSERTION OF BONE GROWTH STIMULATOR ON 1/9/92. BONE GROWTH STIMULATOR REMOVED DURING COURSE OF SURGERY FOR DECOMPRESSION OF SACRAL NERVE ROOT 9/3/92. TISSUE FROM BATTERY SITE SENT TO PATHOLOGY, LOCAL NECROSIS NOTED ON PATHOLOGY REPORT. HOSPITAL RECEIVED NOTICE OF LAWSUIT 1/18/94 ALLEGING THAT LEAKAGE OF BATTERY CURRENT HAS CAUSED NERVE DAMAGE TO PATIENT.DEVICE 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 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: OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI BONE GROWTH STIMULATOR IMPLANTABLE SPINAL FUSION STIMULA Implant IMPLANTABLE SPINAL FUSION STIMULATOR LOE EBI MEDICAL SYSTEMS, INC. 720566

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other