BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2101907 · Received May 18, 2011

    Report

    Report Number
    3004209178-2011-03629
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 19, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE RECHARGER SCREEN WAS FROZEN, DISPLAYING THE ANTENNA LOCATOR OPTION. A RECHARGER RESET WAS PERFORMED AND WAS SUCCESSFUL. FOLLOWING THE RESET THERE WERE COUPLING/COMMUNICATION ISSUES. IT WAS SUSPECTED THAT THE INS WAS OVERDISCHARGED. IT WAS UNCLEAR HOW LONG IT HAD BEEN SINCE THE PT LAST RECHARGED THE DEVICE. THE PT WAS SEEN IN CLINIC AND IT WAS NOT POSSIBLE TO RESTORE THE STIMULATION. THE PT WAS IN THE PROCESS OF GETTING APPROVAL FOR INS REPLACEMENT. FURTHER INFO IS BEING REQUESTED AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR ACCESSORY: MODEL 37752, LOT# NKA112970N| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB030875V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB021777V| IMPLANTED:| LEAD: MODEL 3776, LOT# V103242013| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE104608N| LEAD: MODEL 3776, LOT# V063510003| EXPLANTED: