BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1230540 · Received November 13, 2008

    Report

    Report Number
    3004209178-2008-07417
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    August 31, 2008
    Report Date
    October 15, 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

    APPROXIMATELY 1 MONTH LATER, THE PATIENT TURNED STIMULATION BACK ON, AND EXPERIENCED A JOLTING SENSATION IN THE BACK OF THE NECK UP HER HEAD. ANALYSIS OF THE N'VISION MEMORY CARD SHOWED THAT THE PATIENT MADE NUMEROUS ADJUSTMENTS TO THE STIMULATION AMPLITUDE IMMEDIATELY FOLLOWING TURNING THE STIMULATION ON, PRESUMABLY TO FIND A MORE COMFORTABLE SETTING AFTER HAVING THE DEVICE OFF FOR AN EXTENDED PERIOD OF TIME. THE NEUROSTIMULATOR WAS PROGRAMMED TO PROVIDE A 4 SECOND SOFT START. IMPEDANCES ON ELECTRODES 8 AND 10 WERE OVER 10,000 OHMS. THE HCP PROGRAMMED AROUND THE OPEN ELECTRODES. IT WAS REPORTED THAT THE BATTERY CHARGED TO 50-75% FULL IN ABOUT 10 MINUTES AND THEN THE RECHARGER TURNED OFF. ANALYSIS OF THE N'VISION MEMORY CARD SHOWED NO EVIDENCE OF ANY SHORT RECHARGES WITH LARGE BATTERY VOLTAGE JUMPS. THE SHORTEST RECHARGE SESSION WAS 26 MINUTES. THE SESSION WAS STARTED AND STOPPED WHILE THE BATTERY REMAINED IN THE 75TH QUARTILE. 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 ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| EXPLANTED:| LEAD: MODEL 3986A| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37083| IMPLANTED:| EXTENSION: MODEL 37083| IMPLANTED:| RECHARGER: MODEL 37752| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3986A| IMPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37742