BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1350342 · Received December 23, 2008

    Report

    Report Number
    3004209178-2008-08524
    Event Type
    Malfunction
    Date Received
    December 23, 2008
    Date of Event
    November 1, 2008
    Report Date
    December 1, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    STARTING ABOUT 2 WEEKS AGO, THE PATIENT ONLY FELT STIMULATION WHEN HER BACK WAS ARCHED. THE PATIENT EXPERIENCED INTERMITTENT STIMULATION AND A LOSS OF THERAPEUTIC EFFECT. THERE WAS NO KNOWN INCIDENT OR ACCIDENT RELATED TO THE COMPLAINT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR IMPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081| EXTENSION: MODEL 37081| EXPLANTED:| LEAD: MODEL 3776| ACCESSORY: MODEL RECHARGER| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3778