BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2806861 · Received October 26, 2012

    Report

    Report Number
    3004209178-2012-09631
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Report Date
    September 28, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# V053074, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION AND HIS DEVICE WAS TURNING OFF AT HOME DUE TO INTERFERENCE. THE PATIENT HAD MET WITH THE MANUFACTURER REPRESENTATIVE WHO HAD PROGRAMMED THE DEVICE BUT NOTICED THE RIGHT AND LEFT WAS 'TREMORING' AND THE RIGHT WAS 'TREMORING' DUE TO THE DEVICE BEING OFF. IT WAS NOTED THAT THE RIGHT SIDE IMPLANT STAYS ON BUT THE LEFT WAS TURNING OFF AT HOME. PER THE MANUFACTURER DEVICE REGISTRY ONLY ONE DEVICE APPEARED TO BE REGISTERED TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1