BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2041453 · Received March 24, 2011

    Report

    Report Number
    3004209178-2011-02282
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 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

    THE PT WAS ONLY ABLE TO FEEL STIMULATION ON THE RIGHT SIDE AND NO LONGER ON THE LEFT SIDE FOLLOWING A MYELOGRAM CT SCAN. EVERYTHING WAS WORKING FINE PRIOR TO THE SCAN. HE TURNED HIS DEVICE OFF BEFORE HE WENT YESTERDAY AND LEFT IT OFF ALL DAY, JUST LAID IN BED WHEN HE GOT BACK HOME. WHEN HE WENT TO TURN IT ON THIS MORNING IT ONLY WORKED ON THE RIGHT SIDE, REAL INTENSE, NOTHING ON THE LEFT. THE MYELOGRAM CT SCAN WAS JUST ABOVE WHERE LEAD GOES INTO THE SPINE. THE SCAN WAS DONE FOR HIS OTHER BACK PROBLEMS, NOT DEVICE RELATED. HE WAS AT HOME. ADDITIONAL INFO HAS BEEN REQUESTED.

    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 58 YR EXPLANTED:| IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA133877N| LEAD: MODEL 3777, LOT # V147729035| LEAD: MODEL 3777, LOT # V087301007| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE138098N