BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2001544 · Received January 26, 2011

    Report

    Report Number
    3004209178-2011-00636
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 12, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO, THE PT WAS UNABLE TO ADJUST STIMULATION, REPORTS SEEING THE EMPTY PT PROGRAMMER BATTERIES. NOT ABLE TO ADJUST STIMULATION WITH OR WITHOUT THE ANTENNA. ALSO NOT ABLE TO RECHARGE THE INS. MEDTRONIC REP REPORTS DEVICE IS SHOWING A POWER ON RESET MODE. BATTERY IS SHOWING EMPTY, BUT NOT OVERDISCHARGED. PT WAS INSTRUCTED TO CHARGE UNTIL 1/4 FULL AND THEN REP WILL CLEAR THE POR. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    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 45 YR EXTENSION: MODEL 37081, LOT# NJB055723V| EXPLANTED:| IMPLANTED:| PROGRMMMER: MODEL 37743, LOT# NKE129614N| ACCESSORY: MODEL 37752, LOT# NKA142958N| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB053474V| EXPLANTED:| LEAD: MODEL 39286-30, LOT# N210570001