BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 4100212 · Received September 18, 2014

    Report

    Report Number
    3004209178-2014-17341
    Event Type
    Death
    Date Received
    September 18, 2014
    Date of Event
    June 10, 2014
    Report Date
    August 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2014-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON 2014-(B)(6) THAT THE PATIENT PRESENTED TO THE ER (EMERGENCY ROOM) WITH A DECREASED LEVEL OF CONSCIOUSNESS. AT 8:00AM, ON THE MORNING OF THE DATE OF THIS REPORT, THE PATIENT ¿STARTED ACTING WEIRD¿ WHILE DRIVING IN THEIR CAR FROM (B)(6). THE PATIENT STARTED TRYING TO OPEN THE DOOR WHILE THE CAR WAS MOVING. THE PATIENT WAS THEN BROUGHT TO THE ER FOR EVALUATION DUE TO THE DECREASED LOC (LEVEL OF CONSCIOUSNESS). THE HEALTH CARE PROVIDER (HCP) WAS ¿QUESTIONING HOW TO IDENTIFY IF THE PUMP IS MALFUNCTIONING¿. THE PUMP HAD LAST BEEN PROGRAMMED ON 2014-(B)(6). NO NARCAN HAD BEEN GIVEN BUT IT WAS THEY WERE CONSIDERING IT. THE PATIENT WAS RESPONSIVE TO QUESTIONS. BLOOD WORK WAS BEING DONE AND THE PATIENT APPEARED TO HAVE ¿SLIGHT CONFUSION/DOESN¿T KNOW WHERE SHE IS¿ BUT RECOGNIZED FAMILY MEMBERS. IT WAS ALSO NOTED THE PATIENT HAD A HIGH FEVER. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE AND AS OF THE LAST PROGRAMMING THE CONCENTRATION WAS 0.5MG/ML AT A DOSE OF 0.10499MG/DAY. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT SYMPTOMS WERE CAUSED BY PNEUMONIA. THE PATIENT EXPIRED. THE PUMP WAS NOT EXPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DIED FROM COMPLICATIONS RELATED TO PNEUMONIA AND IT WAS NOT AT ALL RELATED TO THE IMPLANTED PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578283 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Death