BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2767387 · Received October 1, 2012

    Report

    Report Number
    3004209178-2012-08742
    Event Type
    Injury
    Date Received
    October 1, 2012
    Report Date
    September 1, 2012
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID (B)(4), LOT#, SERIAL# (B)(4), IMPLANTED:, EXPLANTED:, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID (B)(4) LOT#, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED:, PRODUCT TYPE: EXTENSION. PRODUCT ID (B)(4), LOT#, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: PRODUCT TYPE: EXTENSION. PRODUCT ID (B)(4), LOT# V157349, SERIAL#, IMPLANTED: (B)(6) 2008, EXPLANTED:, PRODUCT TYPE: LEAD. PRODUCT ID (B)(4), LOT# V153396, SERIAL#, IMPLANTED: (B)(6) 2008, EXPLANTED:, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEEP BRAIN STIMULATOR (DBS) SHOCKED AND JOLTED A PATIENT. THE PATIENT WAS SHOCKED AND JOLTED TWICE, CAUSING "FREEZING" IN THE RIGHT AND LEFT ARMS AND FACIAL DRAWING FOR 10 SECONDS THE FIRST TIME, AND "FREEZING" IN THE RIGHT ARM AND LEG WITH FACIAL DRAWING FOR 30 SECONDS THE SECOND TIME. HER BALANCE WAS ALSO "OFF." SHE WENT TO AN EMERGENCY ROOM, WAS PUT IN THE HOSPITAL, RECEIVED A COMPUTED TOMOGRAPHY (CT) SCAN, TURNED OFF HER DEVICE, AND THE SHOCKING/JOLTING STOPPED. AT AN APPOINTMENT 4 DAYS LATER, THE DEVICE WAS TURNED ON AGAIN, AND SHE WAS JOLTED IN THE SAME WAY. IMPEDANCE WAS CHECKED AND THE VOLTAGE WAS LOWERED. HER DEVICE WAS REPROGRAMMED. THE HCP READ THE CT SCAN AND "IT LOOKED LIKE HER LEFT LEAD HAD PULLED OUT SOME." SHE WILL BE SEEN AGAIN IN ONE MONTH. THE PATIENT WAS LISTED AS "NO INJURY/NO ADVERSE EVENT."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R