BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4366625 · Received December 29, 2014

    Report

    Report Number
    3004209178-2014-24607
    Event Type
    Injury
    Date Received
    December 29, 2014
    Report Date
    December 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3387S-40, LOT# V081575, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V081575, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED 4 DAYS AFTER IMPLANT THE PATIENT HAD A SEIZURE AND STOPPED BREATHING. THEY WERE DIFFERENT THAN THE ONES HE WOULD HAVE BEFORE WHEN ¿HE WOULD SWALLOW.¿ THE PATIENT HAD TWO OTHER SEIZURES ON (B)(6) 2014 AND (B)(6) 2014. THEY WOULD SEE ¿BRIGHT LIGHTS LIKE FIREWORKS¿ AND THE PATIENT HAD FALLEN OUT OF THEIR BED AS WELL. THEY WERE NOT SURE HOW THAT HAPPENED SINCE ¿THEIR FEET WERE WHERE HIS HEAD SHOULD HAVE BEEN AND THEY DID NOT KNOW HOW HE HAD GOTTEN IN SUCH A SMALL SPACE.¿

    Description of Event or Problem · 1

    FOLLOW-UP INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THERE WAS 50% OR GREATER SYMPTOM REDUCTION. THE CAUSE OF THE EVENT WAS NOT DETERMINED, BUT IT WAS NOT DEVICE RELATED. THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT, BUT NOT A LOSS OF STIMULATION. REPROGRAMMING WAS NEEDED. THE PATIENT DIED, BUT IT WAS NOT CONSIDERED DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853928 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Other