BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1170687 · Received September 16, 2008

    Report

    Report Number
    3004209178-2008-05779
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 21, 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

    Description of Event or Problem · 1

    THE PATIENT WAS LYING IN BED AND SHE NOTICED THAT THE STIMULATION SHUT OFF. SHE TRIED TO TURN IT UP AND STILL COULD NOT FEEL STIMULATION. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT. THE NEXT DAY, THE BATTERY WAS CHECKED AND FOUND TO BE FULLY CHARGED. THE STIMULATION WAS TURNED UP TO 10.5 VOLTS AND THE PATIENT STILL COULD NOT FEEL STIMULATION. IMPEDANCES WERE CHECKED. THE ONLY VIABLE PAIR WAS 1, 3 WITH AN IMPEDANCE OF 228 OHMS; ALL OTHER PAIRS WERE >3600 OHMS. A REVISION OF THE LEAD AND EXTENSION WAS PLANNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HEALTH CARE PROFESSIONAL, A FOLLOW-UP REPORT WILL BE SENT 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 53 YR Required Intervention EXPLANTED:| LOT# UNKNOWN| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37742| EXTENSION: MODEL EXTENSION| ACCESSORY: MODEL 37752| UNKNOWN CONVERSION TYPE: MODEL LEADN