BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1932075 · Received November 30, 2010

    Report

    Report Number
    3004209178-2010-10015
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 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

    IT WAS THOUGHT THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IN AN OVERDISCHARGED STATE BECAUSE THEY WERE UNABLE TO GET TELEMETRY FROM ANY COMPONENT. WHEN THE ANTENNA LOCATE ACTION WAS PERFORMED, IT SHOWED A POR (POWER ON RESET) CONDITION. THEY PLANNED TO CHARGE THE INS AND THEN THEY WOULD CLEAR THE POR. 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 ADVANCED RECHARGEABLE LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR IMPLANTED:| LEAD: MODEL 3778, LOT# V295189009| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V295189008| ACCESSORY: MODEL 37752, LOT# NKA129715N| PROGRAMMER: MODEL 37743, LOT# NKE128814N| EXPLANTED: