BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 2170040 · Received July 18, 2011

    Report

    Report Number
    3007566237-2011-05533
    Event Type
    Death
    Date Received
    July 18, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 27, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS ADMITTED TO ER WITH RESPIRATORY DEPRESSION. UPON PUMP INTERROGATION THE LOGS DISPLAYED "PUMP STOPPED DUE TO SAFETY COUNT". THE PUMP HAD THE DOSAGE RESET AND THE PT WAS MANAGED AS AN INPATIENT FOR SEVERAL DAYS BEFORE GOING HOME. IT WAS LATER REPORTED THAT THE PT HAD PASSED AWAY DUE TO SEPSIS AT HOME. AN ALARM NOT HEARD BUT CONFIRMED BY TELEMETRY WAS ALSO REPORTED. THE PUMP WOULD BE RETURNED FOLLOWING AUTOPSY FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R