BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2050073 · Received March 31, 2011

    Report

    Report Number
    3004209178-2011-02447
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 15, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO THE PT WAS EXPERIENCING A LOSS OF STIMULATION ON HER LEFT SIDE. PT HAD PAIN BEHIND HER LEFT KNEE NOT COVERED BY HER STIMULATION. PT IS ALSO HAVING RELATED ISSUES WITH DISCS IN HER CERVICAL SPINE. SHE IS SCHEDULED FOR A CT MYELOGRAM AND EMG OF HER NECK AND ARM. AT THE TESTS THE HCP CONFIRMED HER LEADS HAD NOT MOVED. PHYSICIAN ASKED FOR THE MFR'S REP TO TRY REPROGRAMMING THE DEVICE TO PROVIDE BETTER COVERAGE FOR THE PT'S PAIN. ADD'L INFO RECEIVED STATED THE PT WAS INVOLVED IN A CAR ACCIDENT AND EXPERIENCED A FALL ALL IN THE SAME WEEK. DEVICE IMPEDANCE WERE ALL GOOD AND NO DEVICE PROBLEM WAS FOUND. THE REP REPROGRAMMED THE INS. PT USES MAXIMUM AMPLITUDE TO RECEIVED THERAPY. REP RECOMMENDED THE PT WAIT A WEEK OR TWO TO F/U AND SEE IF THEY WOULD HAVE BETTER RESULTS. THE PT HAS BEEN A NO SHOW OR HAS CANCELLED F/U APPOINTMENTS UP TO THIS POINT. IF ADD'L INFO BECOMES AVAILABLE, 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 39 YR IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB077771V| LEAD: MODEL 3776, LOT# V401596018| IMPLANTED:| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA139357N| LEAD: MODEL 3776, LOT# V437668039| EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE148812N| EXTENSION: MODEL 37081, LOT# NJB077361V