BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3251669 · Received July 29, 2013

    Report

    Report Number
    3007566237-2013-02499
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 29, 2013
    Report Date
    June 29, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3389S-40, LOT# VA07RNB, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT SURGERY TO IMPLANT A DEEP BRAIN STIMULATION SYSTEM ON (B)(6) 2013. THERE WERE NO ANOMALIES DURING SURGERY. IT WAS STATED THAT TWO HOURS AFTER THE OPERATIONS, THE PATIENT¿S CONSCIOUSNESS WAS ¿FUZZY.¿ BILATERAL MYDRIASIS WAS ALSO NOTED. REVIEW OF A CT SCAN SHOWED A BILATERAL INTRACRANIAL HEMORRHAGE. IT WAS INDICATED THE PATIENT UNDERWENT A HEMOSTASIS OPERATION OF INTRACRANIAL HEMORRHAGE. THE SUGGESTION OF AN ¿EXPERT¿ WAS THAT THE PATIENT MIGHT HAVE COAGULATION PROBLEMS. IT WAS UNKNOWN WHO THIS EXPERT WAS. INFORMATION RECEIVED THE FOLLOWING DAY INDICATED THE PATIENT WAS IN THE INTENSIVE CARE UNIT AFTER THE ¿HEMORRHAGE RESCUE¿ AND WAS UNDER OBSERVATION. THE PATIENT WAS IN A COMA. A LITTLE LESS THAN A MONTH LATER, IT WAS REPORTED THE PATIENT WAS IN ¿STABLE CONDITION¿ AND IN A ¿VEGETATIVE STATE.¿ A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT WAS STILL IN A COMA AND IN THE ICU. A PATHOLOGICAL EXAMINATION OF THE PATIENT INDICATED CEREBROVASCULAR MALFORMATION. IT WAS ALSO NOTED THE PATIENT WAS IN STABLE CONDITION AND A VEGETATIVE STATE. THE PHYSICIAN THOUGHT THERE WAS NO RELATIONSHIP TO THE PRODUCT QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353696 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| L