BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1675249 · Received April 21, 2010

    Report

    Report Number
    3004209178-2010-03223
    Event Type
    Malfunction
    Date Received
    April 21, 2010
    Date of Event
    March 22, 2010
    Report Date
    March 25, 2010
    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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND A FADING SENSATION FOLLOWING IMPLANT. THE STIMULATION SENSATION ALSO CHANGED WITH MOVEMENT; WHEN PT WAS LYING BACK AND ARCHING BACK, SHE FELT STIMULATION AND FELT INCREASE STIMULATION WHEN PRESSING ON LEAD/EXT AREA. THE PT NEVER HAD GOOD STIMULATION. IMPEDANCE MEASUREMENTS WERE NORMAL. AN X-RAY ON (B)(6)2001, CONFIRMED THAT LEAD HAD MIGRATED OUT OF EPIDURAL SPACE 3/22. PT WILL BE SCHEDULED FOR REVISION. ADDITIONAL INFO WILL BE SUBMITTED WHEN 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 43 YR ACCESSORY: MIODEL 37752, LOT# NKA133036N| LEAD: MODEL 39565-65, LOT# V351419004| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE136638N| STIM ACCESSORY: MODEL 37092, LOT# 228720001