BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3041464 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-04889
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 26, 2013
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3387S-40 LOT# VA05K31, IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 748351 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT THROUGH A METAL DETECTOR DEVICE AT A PRISON. THE PATIENT WAS TOLD THAT IT WAS SAFE TO GO THROUGH THE DETECTOR BY THE SECURITY GUARD. THE INS WAS TURNED ON WHEN THE PATIENT WENT THROUGH THE METAL DETECTOR. FOLLOWING THE EXPOSURE, THE PATIENT REPORTED THAT THE DBS WAS NOT WORKING QUITE AS WELL, AND SHE WAS HAVING MORE TROUBLE WITH THE RIGHT SIDE. IT WAS ALSO REPORTED THAT THE PATIENT SAW THE PATIENT ALERT SCREEN ON THE PATIENT PROGRAMMER. THE ALERT WAS A PROGRAMMED FEATURE THAT THE HCP SET UP TO HAVE THE PATIENT CHECK HER DEVICE EVERY DAY. THE PATIENT CHECKED HER DEVICE WITH THE PROGRAMMER AND DETERMINED THAT THE INS WAS ON AND OKAY. IT WAS NOTED THAT THE PATIENT HAD "OVER DID IT" THE DAY BEFORE, AND THAT MAY HAVE BEEN THE CAUSE OF HER NOT FEELING WELL. 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
    143815 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1