BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 3870310 · Received June 12, 2014

    Report

    Report Number
    3007566237-2014-01624
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    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 PRODUCTS: PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID 977D260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE SCREENING DEVICE; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE HIGH IMPEDANCES. IT WAS REPORTED THE PATIENT WAS UNABLE TO FEEL STIMULATION AT 10.5V. IT WAS NOTED THE IMPEDANCES WERE ELEVATED WHILE THE PATIENT WAS ON THE TABLE BUT IN RECOVERY THE PATIENT COULD FEEL STIMULATION AND THE IMPEDANCES WERE NORMAL. IT WAS REPORTED THE DEVICE WAS REPROGRAMMED AND THE LEAD WAS REPOSITIONED. IT WAS FURTHER NOTED THAT EXTENSIVE TIME WAS SPENT INTRA-OPERATIVELY PROGRAMMING IN AN ATTEMPT TO GET THE PATIENT TO FEEL STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347201 EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1