BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    MDR report key: 3061437 · Received April 16, 2013

    Report

    Report Number
    3007566237-2013-01300
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 30, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-45, LOT# VA073P0008. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BURIED LEAD TRIAL, IMPEDANCES GREATER THAN 40,000 OHMS ON CONTACTS 3,4, AND 5 OCCURRED. OTHER IMPEDANCES ON 0-7 AND 8-15 WERE HIGH AS WELL, IN THE 3000-6000 OHM RANGE. THE TRIALING CABLE WAS REPLACED, WITH NO RESOLUTION. OTHER TROUBLESHOOTING WAS UNSUCCESSFUL, SO A NEW LEAD WAS PLACED. WITH THE NEW LEAD, IMPEDANCES RANGED AROUND 1500-3000 OHMS. THE PATIENT WAS ABLE TO FEEL STIMULATION POST-OPERATIVELY AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163536 UNKNOWN EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1