BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE.

    MDR report key: 1884844 · Received October 15, 2010

    Report

    Report Number
    3007566237-2010-08007
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 20, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINE SURGERY AND "COAGULATION WAS USED," AND THE IMPLANTABLE NEUROSTIMULATOR DOES NOT WORK. THERE WAS NO SUCCESS INTERROGATING BETWEEN THE PROGRAMMER AND THE DEVICE. PATIENT'S DEVICE WAS EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE MADE AS FOLLOW UP AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE. LGW MEDTRONIC NEUROMODULATION 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention