BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 2200840 · Received August 8, 2011

    Report

    Report Number
    3007566237-2011-06139
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOR APPROX THE PAST YEAR, THE PT EXPERIENCED HER STIMULATION SPONTANEOUSLY TURNING ON AND OFF. THE PATTERN WAS VERY INCONSISTENT. TROUBLESHOOTING TOOK PLACE MULTIPLE TIMES, BUT THE CAUSE COULD NOT BE IDENTIFIED. HOWEVER, IMPEDANCES WERE SOMETIMES LOW AT <50 OHMS ON ELECTRODES 4 AND 5. THE NEUROSTIMULATOR MODEL 37702 WAS REPLACED DUE TO BATTERY DEPLETION. THE EXTENSION WAS ALSO REPLACED, BUT THE INCONSISTENT STIMULATION CONTINUED. THE OCTAD LEAD WAS THEN REPLACED AND STIMULATION AND IMPEDANCES WERE NORMAL. THE PT INCURRED NO INJURY AND WAS FINE. REFER TO MFR REPORT # 3007566237201106136 FOR REPORT ON THE PREVIOUS NEUROSTIMULATOR MODEL 37702.

    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 EXTENSION: MODEL EXTENSION, LOT# UNK| IMPLANTABLE NEURO STIMULATOR: MODEL 37702| LOT# UNK| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3877, LOT# B0807645K| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED: