BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2031355 · Received March 16, 2011

    Report

    Report Number
    3004209178-2011-01985
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 2, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT FELT SHOCKING FROM THE IMPLANTABLE NEUROSTIMULATOR FOR A SHORT TIME. IT THEN STOPPED PROVIDING STIMULATION. THERE WAS POOR RECHARGE COUPLING. THE PT STOPPED RECHARGING THE DEVICE ABOUT 2 MONTHS AGO. AN OVERDISCHARGE WAS SUSPECTED. THE PT HAD MOVED AND DIDN'T HAVE INSURANCE. THE LOCAL FIELD REP WAS CONTACTED REGARDING THE SITUATION. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    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 37 YR EXTENSION: MODEL 37081, LOT# NJB033891V| EXTENSION: MODEL 37081, LOT# NJB033897V| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE103372N| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 39565-30, LOT# N150215006| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA117313N