BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3132110 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08253
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V314995, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 3387S-40, LOT# V351366, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 748251, SERIAL# (B)(4). PRODUCT TYPE: EXTENSION: PRODUCT ID 748251, SERIAL# (B)(4). PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS ¿A LITTLE MORE SHAKY¿ AFTER DOING AN ELECTRODE IMPEDANCE TEST. IT WAS NOTED THERE WERE NO IMPEDANCE ISSUES. IT WAS NOTED THE PATIENT WAS SCHEDULED FOR A STIMULATOR REPLACEMENT. STIMULATOR VOLTAGE WAS AT 2.61 VOLTS. STIMULATION WAS ADJUSTED UP TO 3.9 VOLTS WITH VOLTAGE CONTROL UP TO 4.9 VOLTS SET BY THE NEUROLOGIST. THE PATIENT GOT A CHARGE DENSITY WARNING WHEN THEY INCREASED VOLTAGE. IT WAS ALSO NOTED THE PATIENT WAS ADMITTED FOR HIGH BLOOD PRESSURE AND DEHYDRATION. IT WAS UNKNOWN IF THIS WAS RELATED TO THE PROCEDURE OR DEVICE. FOLLOW UP REPORTED THE PATIENT WAS RECEIVING THERAPEUTIC BENEFIT AFTER REPLACEMENT OF THE STIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235503 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization