BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 3201594 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11179
    Event Type
    Death
    Date Received
    July 2, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND NO ANOMALY. ANALYSIS OF THE CATHETER FOUND NO SIGNIFICANT ANOMALY. THE CATHETER WAS INCOMPLETE/ RETURNED IN SEGMENTS AND NO SIGNIFICANT ANOMALY WAS FOUND WITH THE PORTION OF THE RETURNED CATHETER.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, LOT# J10919R64, IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8709, LOT# J10919R64, IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED AND THE CAUSE OF DEATH WAS PENDING. A "FEW DAYS" BEFORE THE DEATH THE PATIENT HAD BEEN TAKEN TO THE EMERGENCY ROOM, HE WAS SUFFERING FROM DAYS OF WITHDRAWAL SYMPTOMS INCLUDING VOMITING AND SHAKES. THEY FOUND THIS WAS DUE TO A "KINKED LINE LEADING FROM HIS IMPLANTED MORPHINE PUMP". THE PATIENT WAS GIVEN FENTANYL PATCHES. THE PATIENT WAS ALSO ON ATIVAN, ZOFRAN, METHADONE, AND VALIUM AT THE TIME. THE PATIENT WENT TO BED ON FRIDAY ((B)(6)) SINCE HE "FELT A LITTLE BETTER" BUT WAS FOUND DEAD AT 3:30 THE NEXT MORNING. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM AT THE TIME OF THE REPORTED EVENT WAS NOT PROVIDED. IT WAS REPORTED THAT THE CAUSE OF DEATH COULD NOT BE "DETERMINED" "UNTIL THEY RECEIVE ANALYSIS OF THE DEVICE". IT WAS REPORTED THAT PRIOR TO DEATH (A DAY OR 2 BEFORE) THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH NARCOTIC WITHDRAWAL SYMPTOMS THEY THOUGHT THE CATHETER WAS KINKED BUT IMAGING TAKEN AT THE HOSPITAL DID NOT SHOW ANY CATHETER ISSUES. THE PATIENT WAS THEN DISCHARGED AND GIVEN ATIVAN. THE NEXT MORNING THE PATIENT WAS FOUND DEAD IN HIS HOME. THE DEVICE SYSTEM HAD BEEN USED TO DELIVER FENTANYL; 29ML OF FENTANYL WERE REMOVED FROM THE DEVICE PRIOR TO ITS RETURN. THE PUMP WAS RETURNED. "VOLUME DISCREPANCY" WAS REPORTED. IT WAS UNKNOWN IF THE PUMP WAS RELATED TO THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301601 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Death| H