BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 3202379 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04630
    Event Type
    Death
    Date Received
    July 2, 2013
    Report Date
    May 1, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709 LOT# J10868R07, IMPLANTED: 2001 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPIRED ON (B)(6) 2012. THE PATIENT¿S FAMILY WANTED TO ¿BLAME THE PUMP IN SOME WAY.¿ THE PATIENT HAD A HEART ATTACK AND WAS ON LIFE SUPPORT FOR SOME TIME. THE PATIENT WAS AT THE INTENSIVE CARE UNIT WITH VENTILATOR. THE PUMP WAS TURNED DOWN ON (B)(6) 2012 AND ON (B)(6) 2012 AT MINIMUM RATE. IT WAS REPORTED THAT THE CAUSE OF THE DEATH WERE RESPIRATORY FAILURE AND PNEUMONIA. THE PATIENT ALSO HAD ACUTE KIDNEY INJURY AND RETROPERITONEAL HEMATOMA. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS NOT DEVICE RELATED. THE PATIENT WAS ON DILAUDID CONC: 40 MG/ML DOSE: 18.6 MG/DAY WAS AT 17.264 MG/DAY AND INCREASED 1.336 MG/DAY WHICH EQUALS A 7.738% INCREASED. DRUG: BUPIVACAINE CONC: 20 MG/ML PREVIOUS DOSE: 8.632 MG/DAY CURRENT (CALCULATED) DOSE: 9.3 MG/DAY DRUG: COMPOUND BACLOFEN CONC: 400 MCG/ML PREVIOUS DOSE: 172.64 MCG/DAY CURRENT (CALCULATED) DOSE: 186 MCG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301004 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Death| H