BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 1150599 · Received September 5, 2008

    Report

    Report Number
    3004209178-2008-05523
    Event Type
    Death
    Date Received
    September 5, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 8, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT PASSED AWAY FOLLOWING DEVICE REPLACEMENT SURGERY. THE PT UNDERWENT REPLACEMENT OF THEIR INTRATHECAL DRUG DELIVERY DEVICE. FOLLOWING THE REPLACEMENT THE PT WAS IN RECOVERY FOR A SHORT TIME AND WAS GIVEN A SHOT OF DILAUDID. THE PT WAS GROGGY BUT WAS BELIEVED TO BE NORMAL FOLLOWING THE SURGERY. THE REPLACEMENT SURGERY TOOK PLACE UNDER GENERAL ANESTHETIC. THE PT PASSED AWAY SOMETIME AFTER THE PROCEDURE. EMERGENCY MEDICAL SVCS WAS CALLED. THE PT'S DEATH IS UNEXPLAINED AT THIS TIME. IT IS UNK WHAT DRUG WAS PLACED IN THE PUMP FOLLOWING IMPLANT OR IF THE DEVICE WAS DELIVERY DRUG AT THE TIME OF THE DEATH. IT WAS REPORTED THE PT'S FAMILY WAS DECLINING TO HAVE AN AUTOPSY PERFORMED. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT RECEIVED AT THE TIME OF THIS REPORT. SEE MFR REPORT #6000030-2008-05522.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| L IMPLANTED| CATHETER MODEL 8709 LOT# J12111R17| EXPLANTED| PROGRAMMER MODEL 8840 LOT# UNK