BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 2874090 · Received December 14, 2012

    Report

    Report Number
    3007566237-2012-03019
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 24, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICE: PRODUCT ID: 3877-45, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS PLACED IN A PATIENT FOR THE PURPOSE OF INTRAOPERATIVE TEST STIMULATION. HIGH, OUT OF RANGE IMPEDANCES WERE OBSERVED FOR THE LEAD AND THE TEST STIMULATION WAS NOT COMPLETED. THE LEAD WAS REPLACED AND THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR DEATH. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1