BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1834573 · Received September 9, 2010

    Report

    Report Number
    3004209178-2010-06892
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    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

    THE PATIENT IS EXPERIENCED A TINGLING AND SHOCKING SENSATION WHEN SHE RAISES HER ARM UP AND DOWN. THE PATIENT HAS DYSTONIA AND WAS UNABLE TO COMMUNICATE VERBALLY. FOLLOW-UP INFORMATION INDICATED THE PATIENT'S DEVICE WAS INTERROGATED AND IMPEDANCES WERE WITHIN NORMAL RANGE WHEN IN A REST POSITION. WHEN SHE MOVED HER ARMS UP AND DOWN SHE DID NOT FEEL A SHOCKING SENSATION AND IMPEDANCE MEASUREMENTS WERE AGAIN NORMAL. THE PATIENT WAS GOING TO FOLLOW-UP WITH HER HEALTHCARE PROFESSIONAL IN 6 WEEKS. SEE MANUFACTURER REPORT #3004209178-2010-06891.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR EXTENSION: MODEL 7482, LOT# NHU0999042V| IMPLANTED:| LEAD: MODEL 3387, LOT# J0537615V| IMPLANTED: