BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1171223 · Received September 22, 2008

    Report

    Report Number
    3004209178-2008-05980
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    March 1, 2008
    Report Date
    August 25, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED THE #0 ELECTRODE SLEEVE HAD BROKEN OFF DUE TO OVERSTRESS/DAMAGE. THE PLACEMENT OF THE LEAD IN THE CERVICAL/NECK AREA AND THE EVENT (CAR ACCIDENT) THE PT WAS INVOLVED IN MOST LIKELY CONTRIBUTED TO THE BREAKAGE OF THE ELECTRODE SLEEVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEW WEEKS FOLLOWING A CAR ACCIDENT, THE PT'S STIMULATION STOPPED WORKING. IMPEDANCE MEASUREMENTS WERE ALL HIGH INDICATING A BROKEN LEAD. X-RAYS REVEALED THE DISTAL MOST ELECTRODE ON THE RIGHT SIDE WAS FRACTURED AND HAD BROKEN FROM THE LEAD. THE ENTIRE SYSTEM WAS REPLACED. THE PT RECOVERED WITH OUT SEQUELA.

    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 Required Intervention EXPLANTED| IMPLANTED| EXPLANTED| LEAD MODEL 3777 LOT# J0546558V| IMPLANTED| LEAD MODEL 3777 LOT# J0546558V