BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1220422 · Received October 31, 2008

    Report

    Report Number
    3004209178-2008-07078
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    September 1, 2008
    Report Date
    October 2, 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
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD RETURN OF SYMPTOMS FOR TWO DAYS AFTER HOLDING A GPS SYSTEM AND BEING NEAR AN ELECTRONIC AIR FILTER WHILE SITTING IN THE BACK SEAT OF A CAR. THE STIMULATOR WAS TURNED ON AFTER TWO DAYS AND THE PATIENT'S SYMPTOMS WENT AWAY AFTER THAT. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, 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 70 YR LEAD: MODEL 3387| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3387| EXTENSION: MODEL 7482| EXPLANTED: