BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1231037 · Received October 30, 2008

    Report

    Report Number
    3004209178-2008-07038
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 3, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING LEAD AND EXTENSION REPLACEMENT, THE PT DID NOT HAVE ANY STIMULATION IN THE BACK (TARGET AREA), THE PT ONLY HAD ABDOMINAL STIMULATION. THIS SUGGESTED LEAD WAS TOO ANTERIOR, BUT IT WAS FELT THAT THIS WAS UNLIKELY SINCE THE NEUROSURGEON PLACED THE LEAD AND THE CORD WAS VERY VISIBLE THROUGH THE LAMINECTOMY. ALSO, THE SURGEON USED THE SAME LUMEN AS THE PREVIOUS LEAD, WHICH PROVIDED GOOD COVERAGE BILATERALLY. THE PT WAS ADMITTED TO THE HOSP AT THE TIME OF THE REPORT. IMPEDANCE MEASUREMENTS WERE NORMAL. NO PT TREATMENT OR OUTCOME WAS REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFERENCE MFR REPORT # 3004209178200807039.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR IMPLANTED:| EXTENSION: MODEL 37082| PROGRAMMER: MODEL 37742| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3998| EXPLANTED: