BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2930986 · Received January 28, 2013

    Report

    Report Number
    3007566237-2013-00287
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 9, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S STIMULATION WAS INTERMITTENT; IT WAS EITHER "NOT WORKING" OR IT WAS PAINFUL. THE PATIENT GOT HIS IMPLANTABLE NEUROSTIMULATOR (INS) THE DAY BEFORE THE REPORT AND HAD NOT BEEN FEELING STIMULATION AT TIMES. HOWEVER, WHEN THE PATIENT MOVED HIS NECK OR ARM, HE STARTED TO FEEL STIMULATION. IT WAS NOTED THAT THIS CONTINUED TO HAPPEN. AT THE TIME OF THE REPORT, THE PATIENT'S STIMULATION WAS OFF, AND HE DID NOT FEEL ANY STIMULATION. STIMULATION WAS THEN TURNED ON, AND IT WAS NOTED THAT THE PATIENT WAS ON PROGRAM 1 AT 1.8 V. HOWEVER, IF THE PATIENT INCREASED STIMULATION TO 2V, IT WAS PAINFUL IN HIS CHEST. THE REPORTER INDICATED THAT THE PATIENT FELT STIMULATION IN HIS NECK AND LEFT ARM, FROM HIS ELBOW TO HIS WRIST. IT WAS NOTED THAT THE PATIENT DID NOT HAVE ANY OTHER PROGRAMS OR GROUPS TO CHOOSE FROM. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37686 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1