BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 1071649 · Received July 9, 2008

    Report

    Report Number
    2182207-2008-03864
    Event Type
    Death
    Date Received
    July 9, 2008
    Report Date
    March 29, 2007
    Manufacturer
    MEDTRONIC, INC., NEUROLOGICAL DIV.
    Product Code
    LKK
    PMA / PMN Number
    P860004/S56
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT. BOTH THE PUMP AND CATHETER WERE RETURNED AND FOUND TO BE WITHIN SPECIFICATIONS. THE DEVICE PROGRAMMER WAS NOT RETURNED. RESULTS: CATHETER.

    Description of Event or Problem · 1

    PRODUCT RECEIVED FROM FUNERAL HOME. CAUSE OF DEATH WAS NOT PROVIDED. PT WAS BEING TREATED FOR PAIN WITH DILAUDID AND CLONIDINE. MANUFACTURER'S REGISTRATION SYSTEM INDICATES THE PT WAS LISTED AS EXPIRED AS OF 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC, INC., NEUROLOGICAL DIV. 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death CATHETER MODEL 8703W LOT# L43068| PROGRAMMER 8840