BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1913544 · Received November 12, 2010

    Report

    Report Number
    9614453-2010-09424
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    April 1, 2010
    Report Date
    October 28, 2010
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S DEVICES WERE TURNING OFF BY THEMSELVES ON A NUMBER OF OCCASIONS, "ONCE IN (B)(6) 2010, TWICE IN (B)(6) 2010, AND TWICE IN (B)(6) 2010." ON EACH OCCASION, THE PT TURNED THE DEVICE BACK ON WITH THE PT PROGRAMMER. NO CAUSE COULD BE DETERMINED. THE DEVICES WERE CONTINUOUSLY USED, AND THE PT WAS RECEIVING EFFECTIVE STIMULATION. REFERENCE MFR REPORT # 9614453201009422

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC EUROPE SARL 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| EXPLANTED:| LOT #NFW642017S