BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3955635 · Received July 24, 2014

    Report

    Report Number
    3007566237-2014-02072
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    November 15, 2013
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IMPLANTED ON (B)(6) 2013 AND ONE MONTH AFTER IMPLANT, THE PATIENT STARTED TO GET ¿SEVER SHOCKS¿ THROUGHOUT THEIR BODY. IT WAS NOTED 8.5 MONTHS AFTER IMPLANT, THE SYSTEM WAS COMPLETELY REPLACED. IT WAS REPORTED THE PATIENT BELIEVED THE ¿LEADS WERE BURNT BETWEEN THE SPINE AND BATTERY¿. IT WAS NOTED THE PATIENT WAS SCHEDULED FOR ONLY A BATTERY REPLACEMENT; HOWEVER, THE ENTIRE SYSTEM WAS REPLACED. IT WAS FOUND THE LEADS WERE THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434703 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention