BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 3931254 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-12939
    Event Type
    Death
    Date Received
    July 14, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    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
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT DATE OF DEATH WAS NOT PROVIDED; (B)(6) 2014 IS AN APPROXIMATE DATE OF DEATH. CONCOMITANT PRODUCT: PRODUCT ID: 8711, LOT# J10942R34, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS AT A CARE CENTER. THE PATIENT STATED ON THE MORNING OF THIS REPORT, THAT HE DID NOT FEEL THE PUMP WAS WORKING. LATER IN THE DAY, THE PATIENT WENT UNRESPONSIVE AND ¿A RAPID RESPONSE WAS ISSUED¿; THE REPORTER EXPLAINED THAT, THAT WAS WHERE EVERYONE COMES INTO THE ROOM TO CARE FOR THE PATIENT. THE PATIENT¿S BLOOD PRESSURE WAS LOW AND HE WAS STILL UNRESPONSIVE. THE PATIENT¿S PUMP MANAGING PHYSICIAN HAD NOT YET BEEN CALLED. THE DEVICE SYSTEM WAS DELIVERING BACLOFEN AND MORPHINE. IT WAS LATER REPORTED THAT THE PATIENT WAS AT A LONG TERM ACUTE CARE FACILITY. THE NEXT PUMP REFILL WAS DUE ON (B)(6). THE PUMP HAD NOT BEEN REFILLED RECENTLY. THE PATIENT LAST HAD ORAL MEDICATION AT 3AM. IT WAS LATER REPORTED THAT THE PATIENT HAD NOT BEEN SEEN BY THEIR PUMP MANAGING PHYSICIAN SINCE END OF (B)(6), BUT AT THAT TIME, THE PATIENT WAS HAVING NO ISSUES WITH THERAPY. THE PUMP MANAGING PHYSICIAN¿S OFFICE HAD NO INFORMATION ABOUT WHAT CAUSED THE PATIENT¿S UNRESPONSIVENESS OR DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411095 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Death| L