BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4090272 · Received September 15, 2014

    Report

    Report Number
    3004209178-2014-17043
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR PRODUCT ID: 3387S-40, LOT# VA0AUE6, 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. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A STROKE LAST THURSDAY, (B)(6) 2014. THE PATIENT HAD BRAIN DAMAGE AND WAS IN A COMA IN THE INTENSIVE CARE UNIT. THE PATIENT¿S DAUGHTER INQUIRED ABOUT HOW TO TURN STIMULATORS OFF AND HAD INQUIRED IF THE STIMULATION WAS TURNED ON IF IT WOULD HELP THE PATIENT¿S CONDITION, MENTAL STATUS. IT WAS NOTED THAT THERE WOULD BE NO REPERCUSSIONS TO TURNING THE DEVICE OFF. THE PATIENT¿S IMPLANTING HEALTHCARE PROFESSIONAL HAD NOT KNOWN OF ANY MALFUNCTION AND THEY HAD NOT HEARD THAT THERE WAS ANYTHING OUT OF THE ORDINARY WITH THE PATIENT¿S CASE AND THEY ALSO HAD NOT HEARD FROM THEM. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568703 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization| L