BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1250402 · Received December 3, 2008

    Report

    Report Number
    3004209178-2008-07986
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    January 1, 2008
    Report Date
    November 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON 11/19/2008, THE EXTENSION HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 'STIMULATION STOPPED WORKING'. IMPEDANCES WERE GREATER THAN 10,000 OHMS ON ALL BIPOLAR ELECTRODE COMBINATIONS EXCEPT 1 PAIR. THE HCP WAS UNABLE TO PRODUCE STIMULATION COVERAGE WITH THE HIGH IMPEDANCES. THE LEAD WAS FRACTURED AND REQUIRED REVISION. IT IS UNCLEAR IF THE LEAD WAS REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention IMPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37742| LEAD: MODEL 3778| EXPLANTED:| STIM ACCESSORY: MODEL 3550-29| RECHARGER: MODEL 37752| EXTENSION: MODEL 37081