BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3152327 · Received June 7, 2013

    Report

    Report Number
    3004209178-2013-09054
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    May 29, 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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389S-40, LOT# VA02BRF, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# VA03YKJ, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT# VA01PN5, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THE PATIENT WAS ¿UNHAPPY¿ WITH THEIR STIMULATION AFTER HAVING BEEN REPROGRAMMED TWO DAYS PRIOR TO INITIAL REPORT. IT WAS STATED THE PATIENT WAS ¿VERY ANGRY¿ AND THAT THE PATIENT WAS ¿PROBABLY GOING TO SUE¿ THE MANUFACTURER. THE PATIENT¿S PHYSICIAN REPORTED HE BELIEVED THE PATIENT WAS IMPLANTED 3 WEEKS PRIOR TO REPORT. IT WAS STATED THE PATIENT ¿WAS DOING OK, KIND OF, AND HE CAME OUT OF SURGERY DOING TERRIBLE.¿ REGARDING THE PATIENT¿S PROGRAMMING IT WAS NOTED IT WAS ¿THE SECOND OR THIRD OR FOURTH GO AROUND.¿ ADDITIONAL INFORMATION STATED ¿THE PATIENT COULD NO LONGER WALK OR WRITE AND COULD DO BOTH BEFORE HAVING THE DEEP BRAIN STIMULATION (DBS) SYSTEM IMPLANTED.¿ IT WAS ALSO STATED THE PATIENT WAS ¿HAVING PROBLEMS WITH FREEZING.¿ IT WAS REPORTED THE PATIENT WAS ¿WORSE OFF AFTER HAVING DBS THAN BEFORE THE DEVICE WAS IMPLANTED.¿ IT WAS NOTED ¿THERE WAS NO KNOWN CAUSE AND THE ISSUE HAD NOT RESOLVED¿ AND ¿NO INTERVENTIONS HAD TAKEN PLACE.¿ A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252666 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability