BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3793923 · Received May 6, 2014

    Report

    Report Number
    3004209178-2014-08600
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 15, 2014
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# VA0CL8J, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3708640, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708640, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DID NOT HAVE ANY CONCERNS WITH THEIR DEVICE OR THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN ECHOCARDIOGRAM 4 DAYS PRIOR TO REPORT. IT WAS NOTED THEY FELT A ¿ZING¿ WHEN THEY TURNED THE STIMULATION ON SINCE THE ECHOCARDIOGRAM. IT WAS NOTED THE LONGER THEY HAD THE THERAPY ON THE MORE UNCOMFORTABLE THEY FELT. IT WAS STATED THEY FELT A CHANGE IN THERAPY RIGHT AFTER THE ECHOCARDIOGRAM APPOINTMENT. IT WAS NOTED THEY WERE TOLD TO TURN THE VOLTAGE DOWN. IT WAS STATED THEY WERE UNSURE IF THE ECHO DEVICE WAS KEPT 6 INCHES AWAY FROM THE IMPLANTABLE NEUROSTIMULATOR (INS) THE ENTIRE TIME. IT WAS NOTED THEY DID NOT HAVE ANY FALLS OR TRAUMA. IT WAS FURTHER REPORTED THE PATIENT HAD TINGLING IN THEIR FINGERS AND TEETH. IT WAS STATED IT WAS UNKNOWN IF THERE WERE AN ABNORMAL IMPEDANCE MEASUREMENTS. IT WAS STATED THE PATIENT HAD EXPERIENCED A SIGNIFICANT ¿ZAP¿ WHEN THE STIMULATION WAS TURNED BACK ON. IT WAS NOTED THE PATIENT FELT BETTER AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270802 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR