BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2841326 · Received November 21, 2012

    Report

    Report Number
    3007566237-2012-02799
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 22, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD OPEN HEART SURGERY (DATE NOT REPORTED) AND IT WAS NOTED THAT THE SURGEON HAD DIFFICULTY OPERATING DUE TO THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THE PATIENT'S TENS UNIT INTERFERED WITH THE ELECTROCAUTERY. IN ADDITION, THE PATIENT STATED THAT THEY WERE UNABLE TO ADJUST THE STIMULATION AND THAT THE INS HAD NOT WORKED FOR THE PAST 2 YEARS WITH THE RESULT THAT THEY WERE IN PAIN. IT WAS UNCLEAR IF THE INS BATTERY HAD REACHED AN END-OF-SERVICE CONDITION. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1