BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEU_INS_STIMULATOR

    MDR report key: 2980316 · Received February 27, 2013

    Report

    Report Number
    3007566237-2013-00610
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    February 5, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD "MALFUNCTIONING" STIMULATION. IT WAS STATED THE PATIENT SAID HE HAD 16 BACK SURGERIES INCLUDING A FAILED ATTEMPT AFTER HIS MALFUNCTIONING STIMULATION. REPORTEDLY, THE PATIENT HAD NOT HAD BACK SURGERY IN SEVERAL YEARS AND WAS CURRENTLY NOT SEEING HIS HEALTHCARE PROVIDER BECAUSE HE HAD RECENTLY MOVED TO MICHIGAN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83678 NEU_INS_STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1