BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1231157 · Received November 12, 2008

    Report

    Report Number
    3004209178-2008-07376
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 15, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INTERMITTENT STIMULATION. IT WAS ALSO REPORTED THAT THE STIMULATOR WOULD NOT FUNCTION OR RESPOND TO THE PATIENT PROGRAMMER. THE PATIENT NOTED THE SYMPTOMS FOLLOWING EXPOSURE TO A SECURITY GATE AT THE AIRPORT. IT WAS REPORTED THAT THE DEVICE WAS TURNED ON DURING THE EXPOSURE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S DEVICE WAS INTERROGATED AND IT WAS REPORTED THAT THE BATTERY WAS DEAD. THE PATIENT WAS OUT OF THE COUNTRY AT THE TIME, AND DECIDED TO CONTINUE HIS VACATION AND SPEAK WITH HIS PHYSICIAN WHEN HE RETURNED HOME. THE MANUFACTURER'S DEVICE TRACKING SYSTEM INDICATED THAT THE STIMULATOR WAS REPLACED. NO PATIENT OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482| LEAD: MODEL 3389