BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 4960184 · Received August 3, 2015

    Report

    Report Number
    3004209178-2015-14486
    Event Type
    Death
    Date Received
    August 3, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 13, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANT DATE CORRECTED TO (B)(6) 2015, EXPLANT DATE: CORRECTED TO UNKNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2015 ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN'S OFFICE AND PER THIS REPORTER THE PATIENT DIED ON (B)(6) 2015. SHE STATED THAT THE PATIENT WAS FOUND UNRESPONSIVE AND FULLY CODED AND AFTER THIS THE PATIENT WAS ESSENTIALLY BRAIN DEAD AND HE PASSED AWAY ON (B)(6) 2015. SHE STATED THAT THE PUMP WAS NOT SUSPECTED TO BE RELATED TO THE PATIENT'S DEATH AT ALL AND NO AUTOPSY WAS CONDUCTED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE PATIENT WAS IMPLANTED WITH A NEW INFUSION SYSTEM. THE DOSE WAS STARTED AT 100 MCG/DAY. THE PATIENT HAD GOOD RELIEF AT THAT DOSE SO THE PHYSICIAN DECIDED TO UP THE DOSE TO 119 MCG/DAY. THE PATIENT¿S MOTHER NOTICED DRAINAGE FROM THE PATIENT¿S BACK INCISION AND THE PHYSICIAN DECIDED TO MONITOR DUE TO THE PATIENT¿S MEDICAL HISTORY OF BEING PRONE TO INFECTION. ON SATURDAY ((B)(6) 2015) MORNING THE DRAINAGE CONTINUED SO THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM AND THE INCISION WAS OPENED. CULTURES WERE TAKEN AT THAT TIME; NO OTHER ISSUES WERE SEEN. THE PHYSICIAN PLACED A DRAIN. THE PATIENT WAS HOSPITALIZED RELATED TO THE EVENT. ON (B)(6) 2015 AT APPROXIMATELY 5PM THE PATIENT WENT INTO FULL CODE; CARDIAC ARREST AND RESPIRATORY ARREST. THE PATIENT WAS CONSIDERED BRAIN DEAD. THE PATIENT EXPIRED. THE PATIENT¿S SPINAL FLUID WAS POSITIVE FOR GRAM NEGATIVE BACTERIA. THE DEVICE SYSTEM WAS DELIVERING LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503812 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00028 YR Death| H| L| R