BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1427081 · Received April 27, 2009

    Report

    Report Number
    3004209178-2009-02925
    Event Type
    Malfunction
    Date Received
    April 27, 2009
    Date of Event
    March 30, 2009
    Report Date
    March 30, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STIMULATION WAS TURNING OFF. IT OCCURRED TWICE OVER THE LAST COUPLE OF DAY PRIOR TO THE REPORT. THE SYMPTOMS OCCURRED FOLLOWING A POSITION CHANGE. THE FIRST TIME, THE PATIENT SAT UPRIGHT AND TIGHT AGAINST A PEW AT CHURCH AND THE IMPLANTABLE NEUROSTIMULATOR (INS) SHUT OFF. THE SECOND TIME, THE PATIENT WAS SITTING IN A RESTAURANT BOOTH AND THE INS SHUT OFF AGAIN. MOVEMENT CAUSED STIMULATION CHANGES. IT WAS REPORTED THAT THE PATIENT PROGRAMMER VERIFIED THAT THE INS WAS OFF. RECHARGING HAD BEEN NORMAL. THERE WERE NO PROBLEMS ASSOCIATED WITH THE ISSUE, AND IT DID NOT RECUR AFTER THESE TWO EVENTS. THE PATIENT WAS GOING TO CONTINUE TO MONITOR AND CONTACT HIS PHYSICIAN IF THE ISSUE RECURRED. NO INTERVENTION WAS PROVIDE.

    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 51 YR PROGRAMMER: MODEL 37743| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778| EXPLANTED:| LEAD: MODEL 3778