BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INS_STIMULATOR

    MDR report key: 2963766 · Received February 15, 2013

    Report

    Report Number
    3007566237-2013-00499
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    January 29, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S LEADS AND IMPLANTABLE NEUROSTIMULATOR WERE REPLACED AND HE WAS GETTING GOOD THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF STIMULATION FOLLOWING A LEAD REVISION WHICH TOOK PLACE ON (B)(6) 2013. PRIOR TO THE REVISION, IT WAS STATED, ONE LEAD WAS WORKING BUT NOT PLACED IN THE CORRECT LOCATION TO COVER THE PATIENT'S PAIN. THE OTHER LEAD WAS REPORTED TO HAVE HAD FOUR CONTACTS THAT READ >4000 OHMS OR OPEN. THE PATIENT'S DEVICE WAS PROGRAMMED USING THE VIABLE ELECTRODES AND THE PATIENT STATED THEY COULD NOT FEEL THE STIMULATION. DURING THE REVISION PROCEDURE, THE NEUROSTIMULATOR WAS UNHOOKED AND THE PATIENT'S LEADS WERE TESTED USING A MULTI-LEAD TRIALING CABLE. INTRAOPERATIVELY AND FOR HOURS POSTOPERATIVELY, THE PATIENT WAS ABLE TO FEEL STIMULATION WHILE USING THE FOUR VIABLE CONTACTS. THE MORNING FOLLOWING THE REVISION, THE PATIENT STATED THEY COULD NO LONGER FEEL THE STIMULATION. THAT SAME DAY, IMPEDANCE TESTING WAS DONE ON THE PATIENT'S DEVICE AND IT WAS STATED IT "BLOWS PATIENT UP," SO THE EMERGENCY OFF BUTTON WAS USED BECAUSE THE PATIENT WAS "SO UNCOMFORTABLE." THE CALLER ALSO INDICATED THAT THE 8-15 LEAD HAD MIGRATED AND WAS "ANTERIOR." IT WAS ALSO STATED THAT THE PATIENT CAN ONLY FEEL STIMULATION ON CONTACTS 0 THROUGH 4 ON THE 0-7 L EAD. THE NIGHT OF (B)(6) 2013, THE PATIENT REPORTED THE STIMULATION WAS TURNING ON AND OFF RANDOMLY. ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66686 NEU_INS_STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention