BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 2170028 · Received July 18, 2011

    Report

    Report Number
    3004209178-2011-05502
    Event Type
    Death
    Date Received
    July 18, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 27, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE (B)(6), PT, UNDERWENT A PUMP REPLACEMENT PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN HAD CUT THE CATHETER. THE CATHETER AND PUMP WERE BOTH REPLACED. THE PT WAS MONITORED FOR THE POST SURGERY PERIOD, AND IT WAS NOTED THAT "EVERYTHING WAS OK". THE PT SUBSEQUENTLY DIED OF SUDDEN CARDIAC DEATH DURING THE NIGHT. THE PHYSICIAN HAD DECIDED NEITHER TO EXPLANT THE SYSTEM, NOR PROCEED WITH A POST-MORTEM EXAMINATION. THE PUMP INFUSED LIORESAL 500 MCG/ML, DAILY DOSE 49.97 MCG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R EXPLANTED:| CATHETER: MODEL 8731SC, LOT# 0204763219| IMPLANTED: