BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 2690719 · Received August 10, 2012

    Report

    Report Number
    3004209178-2012-06753
    Event Type
    Death
    Date Received
    August 10, 2012
    Report Date
    July 17, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE CATHETER, PRODUCT ID 8590-1, LOT# N182853, IMPLANTED: 2009-(B)(6), PRODUCT TYPE ACCESSORY. (B)(4). FINAL ANALYSIS OF THE PUMP BY THE MANUFACTURER REVEALED NO ANOMALY FOUND; LAST REFILL DATE OF (B)(6)2011, PER PUMP LOGS. THE SUTURELESS CONNECTOR ASSEMBLY + PROXIMAL CATHETER WERE RETURNED. THERE WERE TEARS/CORING NOTED IN THE CUP OF THE SC CONNECTOR. NO LEAKING OR OTHER ANOMALIES WERE SEEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. THE PATIENT WAS IN/OUT OF HOSPITAL FOR WOUND CARE AND URINARY TRACT INFECTIONS (UTI). ON (B)(6) 2011 THE PATIENT WAS ADMITTED TO (B)(6) HOSPITAL FOR WOUND CARE. IT WAS NOT SPECIFIED WHERE THE WOUND WAS. PATIENT WAS PARAPLEGIC DUE TO A PAST MOTOR VEHICLE ACCIDENT. ON (B)(6) 2011, THE PATIENT SUDDENLY LOST HIS PULSE AND WENT INTO CARDIAC ARREST. ADVANCED LIFE SUPPORT WAS INITIATED WITHOUT SUCCESS, AND THE PATIENT WAS PRONOUNCED AT 2154 ON (B)(6) 2011. THE CAUSE OF DEATH WAS NOTED TO BE "METHADONE INTOXICATION"; MANNER OF DEATH "ACCIDENT (PRESCRIPTION DRUG ABUSE)". IT WAS LATER REPORTED, PER THE MEDICAL EXAMINER, THAT THE LEVEL OF METHADONE IN THE DECEASED'S SYSTEM WAS HIGHER THAN WHAT WAS PRESCRIBED. THE MEDICATION IN THE PUMP WAS BACLOFEN PER PUMP LOGS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death