BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4171323 · Received October 14, 2014

    Report

    Report Number
    3007566237-2014-02982
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    September 24, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN; PRODUCT TYPE LEAD PRODUCT ID NEU_PTM_PROG, SERIAL# UNKNOWN; PRODUCT TYPE PROGRAMMER, PATIENT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) HAD WORKED ¿GREAT¿ FOR 2 MONTHS, BUT THEN STARTED ¿SLIDING OFF.¿ THE PATIENT HADN¿T BEEN ¿MUCH BETTER OFF, IF NOT WORSE.¿ AFTER GETTING THE IMPLANT, THE PATIENT WAS STILL IN PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650584 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1