BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2030405 · Received March 9, 2011

    Report

    Report Number
    3004209178-2011-01793
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 23, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO THE PT SUFFERED A FALL ABOUT ONE MONTH AGO AND SINCE THE INCIDENT NO LONGER HAS STIMULATION COVERING HER LOWER BACK. THE INS WAS REPROGRAMMED, BUT WAS STILL UNABLE TO RECAPTURE THE PT'S BACK COVERAGE. IMPEDANCE MEASUREMENTS WERE ALL NORMAL. MFR'S REP ADDED AUTOFILL TO HER PROGRAMS AND THE PT IS GOING TO BE SEEN FOR F/U. AT THAT TIME THE REP WILL SEE IF THE NEW PROGRAMS OFFERED ANY RELIEF. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, A F/U 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 37 YR IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA140096N| PROGRAMMER: MODEL 37743, LOT# NKE142614N| LEAD: MODEL 39565-65, LOT# V392970035