BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2061801 · Received March 30, 2011

    Report

    Report Number
    3004209178-2011-02430
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO THE PT RECHARGER AND PROGRAMMER DISPLAY SHOWED "CALL YOUR DOCTOR" ICON. REPORTING A POWER ON RESET CONDITION. PT WAS INSTRUCTED ON HOW TO CLEAR THE POR CONDITION AND THE PT STATED HE WAS THEN ABLE TO USE HIS PROGRAMMER AS EXPECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR IMPLANTED:| EXTENSION: MODEL 7498, LOT # NED002455N| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE154320N| LEAD: MODEL 3487A, LOT # J0101910V| EXPLANTED:| IMPLANTED: