BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4247641 · Received November 13, 2014

    Report

    Report Number
    3004209178-2014-21468
    Event Type
    Malfunction
    Date Received
    November 13, 2014
    Report Date
    October 26, 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
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387S-40, LOT# V020895, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# V013940, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 7438, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE PATIENT WAS IN A NURSING HOME AND ON THE DATE OF THIS REPORT HAD STARTED TO EXPERIENCE TREMORS. IT WAS NOTED THAT THIS HAD NOT HAPPENED ¿IN YEARS.¿ STIMULATION WAS CONFIRMED ON AND OK FOR BILATERAL IMPLANTS. THERE HAD BEEN NO FALLS OR ACCIDENTS NOTED. NO INTERVENTIONS OR OUTCOME WAS PROVIDED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REFERENCE MANUFACTURER¿S REPORT NUMBER: 3004209178-2014-21467.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731762 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR