BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1213803 · Received October 22, 2008

    Report

    Report Number
    3004209178-2008-06805
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 20, 2008
    Report Date
    September 22, 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
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A SUDDEN STOP OF STIMULATION SENSATION. NO KNOWN INCIDENT OR ACCIDENT WAS RELATED TO THE EVENT. THE MANUFACTURER'S REPRESENTATIVE WAS UNABLE TO OBTAIN COMMUNICATION OR OBTAIN TELEMETRY WITH THE PATIENT'S DEVICE USING THE PHYSICIAN'S PROGRAMMER, RECHARGER, AND THE PATIENT PROGRAMMER. TWO PHYSICIAN MODE RECHARGES WERE DONE WITH THE DEVICE SHOWING 75% FULL BATTERY, BUT THE PATIENT STILL DID NOT FEEL ANY STIMULATION SENSATION. IMPEDANCE READINGS SHOWED 527 OHMS AND 9.3 UA. BIPOLAR READINGS WERE BETWEEN 866 AND 910 OHMS. ALL IMPEDANCES WERE WITHIN NORMAL RANGE. WHEN VOLTAGE WAS INCREASED TO 8-9 VOLTS ON A VARIETY OF ELECTRODES, THE PATIENT FELT A PAINFUL SENSATION IN HIS LEGS THAT FELT LIKE, "SOMEONE INSIDE HIS LEG AND TWISTING HIS LEGS." X-RAYS WERE SCHEDULED, BUT NO RESULTS WERE REPORTED. ADDITIONAL PROBLEM SOLVING WAS NOT ATTEMPTED AS THE PATIENT HAD NOT RETURNED BACK TO THE HCP OFFICE AS REQUESTED BY THE HCP AND MANUFACTURER'S REPRESENTATIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 34 YR Required Intervention IMPLANTED:| PROGRAMMER: MODEL 37742| EXPLANTED:| EXTENSION: MODEL 37083| IMPLANTED:| LEAD: MODEL 3888| ACCESSORY: MODEL 37752| EXPLANTED: