BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4210466 · Received October 29, 2014

    Report

    Report Number
    3004209178-2014-20599
    Event Type
    Injury
    Date Received
    October 29, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387S-40, LOT# VA0J9K0, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD (X2); PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 3708695, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE PATIENT¿S FIRST IMPLANTABLE NEUROSTIMULATOR (INS) BATTERIES, THE FIRST TIME THE THERAPY WAS TURNED ON WAS IN (B)(6). WHEN THE THERAPY WAS TURNED ON THEY COULD NOT SPEAK AND THEY WERE REPROGRAMMED 2 TIMES TO RESOLVE THE ISSUE. THEY FEARED THAT IT WOULD HAPPEN AGAIN AND THEY ONLY WANTED TO TURN THE THERAPY ON WITH THE MANUFACTURER REPRESENTATIVE PRESENT. THE INS WAS REPLACED ON (B)(6) 2014 BECAUSE THE PREVIOUS BATTERY DIDN¿T FUNCTION. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691845 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Required Intervention