BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3080029 · Received April 26, 2013

    Report

    Report Number
    3004209178-2013-06952
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    April 1, 2013
    Report Date
    May 2, 2023
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    UDI-DI
    00613994761071
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# VA01WE5, IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION: PRODUCT ID 37642, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED A BRAIN HEMORRHAGE. IT WAS STATED THAT THE BRAIN HEMORRHAGE WAS DISCOVERED POST-OPERATIVELY ON THE DAY OF THE PROCEDURE. IT WAS INDICATED THAT THE PATIENT WAS IN A REHABILITATION FACILITY. THE PATIENT REPORTEDLY WAS ALIVE WITH INJURY AND REQUIRED HOSPITALIZATION. THE SEVERITY AND LOCATION OF THE HEMORRHAGE WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182382 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603 00613994761071

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Female Hospitalization| O "SEE H10...."