BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1853872 · Received September 7, 2010

    Report

    Report Number
    3004209178-2010-06830
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Report Date
    August 10, 2010
    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

    SEVERAL POWER ON RESET (POR) CONDITIONS WERE REPORTED. STIMULATION INITIALLY HAD TURNED OFF TWICE BY ITSELF, AND THE PT PROGRAMMER WAS THEN USED TO TURN IT BACK ON. ON THE THIRD AND FOURTH EPISODE OF THE ISSUE, THE POR CONDITION WAS DISPLAYED AND THE BATTERY WAS NOTED AT 1/2 FULL. UPON THE SIXTH EPISODE, THE POR CONDITION WAS DISPLAYED THIS TIME ON BOTH THE DEVICE AND THE PT PROGRAMMER, WITH THE BATTERY AT HALF CHARGE. A COMPANY REP CLEARED THE POR. THE PT'S STATUS / OUTCOME WAS NOT REPORTED. ADDITIONAL INFO IS BEING REQUESTED, AND WILL BE PROVIDED IN A F/U REPORT AS IT 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 EXTENSION: MODEL 37082, LOT# NKB002895V| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB002896V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT# V345143| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT# V185450| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE151241N| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA141979N| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT# V344586