BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1885017 · Received October 20, 2010

    Report

    Report Number
    3004209178-2010-08200
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT COULD NOT GET THE IMPLANTABLE NEUROSTIMULATOR (INS) TO WORK AND EXPERIENCED NO STIMULATION SINCE THE PREVIOUS DAY. THE PT WAS STANDING UP TO ADJUST HIS STIMULATION TO LIE DOWN WHEN HE LOST STIMULATION. AT THE SAME TIME, THE PROGRAMMER WAS UNABLE TO COMMUNICATE WITH THE RECHARGER. THERE WAS ABILITY TO COMMUNICATE WITH THE PHYSICIAN PROGRAMMER, BUT NOT THE PT PROGRAMMER AND INS RECHARGER. IMPEDANCE LEVELS WERE NORMAL. A PHYSICIAN RECHARGE MODE WAS ATTEMPTED AND AFTER APPROXIMATELY TWO MINUTES, THE "RECHARGE FLIPPED INTO A NORMAL CHARGING SCREEN WITH 50% ON INS BATTERY." STIMULATION WAS INCREASED TO 1.7V AND THE PT WAS ABLE TO FEEL STIMULATION. THE PT PROGRAMMER WAS ABLE TO COMMUNICATE WITH THE INS AND ADJUST THE PARAMETERS. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 65 YR IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA141799N| IMPLANTED:| LEAD: MODEL 39565-65, LOT# V446253027| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE149514N| EXPLANTED:| IMPLANTED: