BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1172117 · Received September 18, 2008

    Report

    Report Number
    3004209178-2008-05875
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 18, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT CHARGED MORE THAN EXPECTED. SHE RECHARGED FOR AN HOUR, UNTIL SHE SAW THE SPRITES ON THE RECHARGER. THE CHARGE WOULD LAST 12 HOURS. THE RECHARGER WAS BROKEN; THE 'CORD AND CHIP WERE FALLING OUT'. THE PATIENT WAS STILL ABLE TO RECHARGE. THE PATIENT'S WAS DISSATISFIED WITH HER EDUCATION SURROUNDING RECHARGING. IT WAS LATER REPORTED THAT THE SPINAL CORD STIMULATOR HAD MOVED AND WAS REVISED. 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 ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention IMPLANTED:| EXTENSION: MODEL 37081| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743| LEAD: MODEL 39565| EXTENSION: MODEL 37081| IMPLANTED:| RECHARGER: MODEL 37752