BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2101676 · Received May 11, 2011

    Report

    Report Number
    3004209178-2011-03412
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 24, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A POWER-ON-RESET (POR) CONDITION WAS REPORTED ON THE PT'S NEUROSTIMULATOR. INTERROGATION OF THE DEVICE BY THE COMPANY REP SHOWED AN ERROR CODE MESSAGE OF 0200 (WATCHDOG TIMEOUT ERROR). ADD'L INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR ACCESSORY: MODEL 37752, LOT# NKA151033N| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V615274017| IMPLANTED:| LEAD: MODEL 3777, LOT# V638923008| PROGRAMMER: MODEL 37743, LOT# NKE164661N