BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 2883369 · Received December 21, 2012

    Report

    Report Number
    3004209178-2012-12156
    Event Type
    Death
    Date Received
    December 21, 2012
    Report Date
    November 21, 2012
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER: MODEL 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    PATIENT DEATH WAS REPORTED BY A FAMILY MEMBER/FRIEND. IT WAS NOTED THAT A MONTH PRIOR TO THE REPORT, THE PATIENT WAS IN "SO MUCH EXCRUCIATING" PAIN, COULD NOT "KEEP ANYTHING DOWN", GOT DEHYDRATED, WENT TO THE HOSPITAL, WAS "FILLED UP WITH FLUID AND SENT BACK HOME" WITH "SOME PAIN PILLS". DATE OF HOSPITALIZATION WAS NOT REPORTED. IT WAS ALSO NOTED THAT THERE WAS A "POSSIBLE" KINK AND THE PATIENT WAS NOT GETTING MEDICATION. IT WAS LATER REPORTED BY HEALTH CARE PROVIDER (HCP) THERE WERE RECENT "ISSUES" WITH VOLUME DISCREPANCY, THE ACTUAL RESIDUAL VOLUME WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME. HCP SUSPECTED A CATHETER ISSUE, THERE WAS "TALK ABOUT SURGERY TO CHECK ON THE CATHETER" AND "POSSIBLY" TO REVISE IT, BUT WAS NOT ABLE TO RULE IT OUT BECAUSE THE PATIENT DIED. IT IS UNCLEAR WHEN THE DISCUSSION OCCURRED; THE DATE OF DISCUSSION WAS REPORTED AS (B)(6) 2012, AND THEN IT WAS NOTED THE PATIENT WAS SEEN THE DAY BEFORE SHE DIED. THE CAUSE OF DEATH WAS UNKNOWN. IT WAS THEN REPORTED BY THE MORTUARY THAT THE CAUSE OF DEATH WAS NOTED AS SHOCK, RENAL FAILURE AND MENENTARIC ISCHEMIA, NOT DEVICE RELATED. THE DEVICE WAS BURIED WITH THE PATIENT, NOT TO BE RETURNED. THE DEVICE SYSTEM WAS USED TO INFUSE MORPHINE.

    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 00070 YR Death| H