BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEU_ENS_STIMULATOR

    MDR report key: 2364782 · Received December 9, 2011

    Report

    Report Number
    3007566237-2011-09210
    Event Type
    Malfunction
    Date Received
    December 9, 2011
    Report Date
    November 18, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P84001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 3873, LOT# V791111, IMPLANTED: UNKNOWN, EXPLANTED: UNKNOWN. LEAD: MODEL 3873, LOT# V791111, IMPLANTED: UNKNOWN, EXPLANTED: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE PHYSICIAN ATTEMPTED TO USE THE GREEN / BENT STYLET AND IT BECAME CAUGHT ON THE ELECTRODES. THE PHYSICIAN OPENED ANOTHER LEAD AND THIS RESOLVED THE ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1