BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONICS

    MDR report key: 283824 · Received June 28, 2000

    Report

    Report Number
    MW1019193
    Event Type
    Death
    Date Received
    June 28, 2000
    Date of Event
    September 11, 1999
    Report Date
    June 26, 2000
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO RPTR, UNDER THE MAUDE FILES REPORT DATED 11/17/99 IT IS STATED THAT THIS PT'S DEATH WAS NOT RELATED TO A DRUG OVERDOSE. RPTR'S UNDERSTANDING OF THIS WOULD BE THAT WHAT HAS BEEN TOLD BY MEDTRONIC IS THAT "THE PT'S DEATH IS NOT RELATED TO A DRUG OVERDOSE". RPTR TAKES THIS TO MEAN THAT THE FDA WAS INFORMED THAT PT DID NOT DIE FROM A MORPHINE OVERDOSE CAUSED BY PUMP. RPTR IS THE PT'S CHILD AND IS NOT SURE IF FDA WAS INFORMED BY MEDTRONIC OF THE FACT THAT APPROX 10ML OF MORPHINE WAS MISSING FROM THE PUMP RESERVOIR UPON AUTOPSY. TISSUE SAMPLES ARE STILL BEING ANALYZED BUT SPINAL FLUID LEVEL SHOWED A VERY HIGH LEVEL OF MORPHINE. RPTR WANTED TO INFORM FDA OF THE FACTS SINCE IT SEEMS AS THOUGH A PERTINENT PIECE OF INFO WAS DISREGARDED BY MEDTRONIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONICS SYNCHROMED IMPLANTABLE PUMP LKK MEDTRONIC, INC. 8617L18 *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death