BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED

    MDR report key: 3489068 · Received November 26, 2013

    Report

    Report Number
    3007566237-2013-03839
    Event Type
    Death
    Date Received
    November 26, 2013
    Date of Event
    October 27, 2013
    Report Date
    October 29, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATES OF THE DEATHS WERE NOT PROVIDED; THE GIVEN DATE WAS BASED ON THE DATE OF THE ARTICLE¿S PUBLICATION. THE DATES OF THE EVENTS WERE NOT PROVIDED; THE GIVEN DATE WAS BASED ON THE DATE OF THE ARTICLE¿S PUBLICATION. IT WAS NOT POSSIBLE TO MATCH THESE EVENTS WITH ANY PREVIOUSLY REPORTED EVENT. PRODUCT ID: NEU_UNKNOWN_PUMP, SERIAL# UNKNOWN, PRODUCT TYPE: PUMP. PRODUCT ID: NEU_UNKNOWN_PUMP, SERIAL# UNKNOWN, PRODUCT TYPE: PUMP. (B)(4).

    Description of Event or Problem · 1

    WALSH, J. NEUROMODULATION FIELD OFFERS BROAD NEW HORIZONS. STARTRIBUNE. 27 OCT 2013 REPORTED EVENTS: PLI 10: 14 PATIENT DEATHS OVER THE PAST 17 YEARS. PLI 20: AT LEAST 1 PATIENT HAS SUED MEDTRONIC OVER PROBLEMS. PLI 30: AN UNKNOWN NUMBER OF PUMPS HAD TO BE REMOVED DUE TO DEFECT OR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615517 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8617

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R