BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1872202 · Received October 14, 2010

    Report

    Report Number
    3004209178-2010-07935
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    May 1, 2010
    Report Date
    May 13, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    RECEIVED INFO THE STIMULATOR WAS IN A POWER ON RESET MODE. THE PT WAS HELPED BY MEDTRONIC'S TECHNICAL SERVICES TO CLEAR THE POWER ON RESET. LATER INFO RECEIVED REPORTS THE PT IS NO LONGER HAVING ANY DEVICE PROBLEMS.

    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 41 YR ACCESSORY: MODEL 37752, LOT# NKA129837N| LEAD: MODEL 3777, LOT# V244759015| IMPLANTED:| LEAD: MODEL 3777, LOT# V063027027| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE130049N| EXPLANTED:| IMPLANTED: