BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4698970 · Received April 16, 2015

    Report

    Report Number
    3004209178-2015-07357
    Event Type
    Malfunction
    Date Received
    April 16, 2015
    Date of Event
    March 27, 2015
    Report Date
    March 27, 2015
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387S-40, LOT# V052560, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 748925, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A40, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT # V063929, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A BRIEF SHOCKING AND JOLTING SENSATION. THE PATIENT FELT A SLIGHT SHOCKING SENSATION FOR A FEW SECONDS AND THEN NOTHING AFTER THAT. UNTIL NOW, THE PATIENT HAD NOT FELT THIS. A MANUFACTURING REPRESENTATIVE LATER REPORTED THE PATIENT WAS DOING FINE WITH NO PROBLEMS AND THEY WERE STILL RECEIVING THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253057 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR