BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2092992 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-03268
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Report Date
    April 14, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT COULD NOT ADJUST THEIR STIMULATION AND HAD A "CALL YOUR DOCTOR" ICON ON THE PT PROGRAMMER SEEN WITH AN OUT-OF-REGULATION (OOR) CONDITION SEEN. IT WAS CONFIRMED THAT THE PT HAS 3 OOR CONDITIONS. THE PT MET WITH THE COMPANY REP. NO SHORT CIRCUITS WERE SEEN. THE PT WAS RE-EDUCATED TO COMPLETE THE CHARGING ON ONE NEUROSTIMULATOR BEFORE WORKING ON THE OTHER DEVICE (PT HAD 2 DEVICE SYSTEMS). ADD'L INFO WAS REQUESTED. SEE MFR REPORT # 3004209178-2011-03269.

    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 LOT# NKF728071H| ACCESSORY: MODEL 37752, LOT# NKA144682N| LEAD: MODEL 3777, LOT# V557936027| LEAD: MODEL 3777, LOT# V557936025| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB072770V| IMPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE157624N| IMPLANTED:| LEAD: MODEL 3777, LOT# V557936023| EXPLANTED:| IMPLANTABLE NEUROSTIMULATOR: MODEL 37712,| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V557936024| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB072771V