BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1812516 · Received August 16, 2010

    Report

    Report Number
    3004209178-2010-06134
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 15, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METAL TASTE IN MOUTH, LACK OF LEG CONTROL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE STIMULATION IS ON, THERE ARE COGNITIVE CHANGES AND A SHOCKING SENSATION THAT TRAVELS THROUGH THE PT'S ENTIRE BODY. THE PT INDICATED THIS OCCURS WHEN NEAR TELEPHONE POLES/ELECTRICAL WIRES AND WHEN PLAYING 'PLAY STATION 2'. THE PT INDICATED THE DEVICE SOMETIMES TURNS ON SPONTANEOUSLY AND SHOCKING OCCASIONALLY OCCURS WHEN THE INS IS TURNED OFF. THE PT IS FEELING ANXIETY AND BUZZING IN THEIR HEAD WHEN THE STIMULATION IS ON MAKING IT DIFFICULT TO THINK. THERE IS A METAL TASTE IN THEIR MOUTH AND NUMBNESS ON THE LEFT SIDE OF THEIR FACE AND DOWN THE LEFT LEG. THERE IS LACK OF CONTROL OF THE LEFT LEG. THE PT HAS NOT HAD THE DEVICE CHECKED IN 3 YEARS; THE PT CANNOT LOCATE THEIR ORIGINAL MD, HOWEVER, THEY HAVE HAD REPROGRAMMING IN THE PAST. ADDITIONAL INFO HAS BEEN REQUESTED; A FOLLOW-UP WILL BE SENT WHEN ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0063844N| IMPLANTED:| LEAD: MODEL 3387, LOT# L71658