BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2760155 · Received September 26, 2012

    Report

    Report Number
    3004209178-2012-08523
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    August 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3 7085-60, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3387S-40, LOT# V591641, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3387S-40, LOT# V754192, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS "SUSPECTED SECURITY DEVICE AT A STORE." IT WAS NOTED THAT THE PATIENT WAS ABLE TO GET HER DEVICE TURNED BACK ON. THE PATIENT'S SYMPTOMS ASSOCIATED WITH THE EVENT WERE NOTED AS INCREASED TREMOR. THE PATIENT DID REQUIRE HOSPITALIZATION AND PATIENT OUTCOME WAS NOTED AS RECOVERED WITHOUT SEQUELAE. FURTHER INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH HER DEVICE. SHE HAD NO APPOINTMENTS SET, AS THE DEVICE GOT TURNED OFF DUE TO A SECURITY GATE AT A DEPARTMENT STORE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT LOSS THERAPEUTIC EFFECT. SYMPTOMS STARTED AFTER EXPOSURE TO MULTIPLE THEFT DETECTORS. PATIENT WAS NO ABLE TO ADJUST STIMULATION. ICON "CALL YOUR DOCTOR" WAS DISPLAYED. POWER-ON-RESET (POR) MASSAGE WAS DISPLAYED ON (B)(6) 2012. DURING THIS REPORT, STIMULATION WAS TURNED ON AND PATIENT REPORTED A "SHOCK" SENSATION, "A RUSH ALL OVER HER" FEELING AND "A METALLIC TASTE" IN THE MOUTH. PATIENT HIT THE HEAD ON THE HEADBOARD. 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 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1