BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED

    MDR report key: 4821473 · Received June 5, 2015

    Report

    Report Number
    3007566237-2015-01567
    Event Type
    Death
    Date Received
    June 5, 2015
    Report Date
    May 27, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER REPORTED SEEING SEE 4 DEATHS ON THE INTERNET ASSOCIATED WITH THE PUMP. THE PUMP MOTOR STALLED. THE DEVICES WERE DELIVERING BACLOFEN. THE REPORTER DIDN'T KNOW THE STATE OR ANY MORE DETAILS. FURTHER FOLLOW-UP IS NOT POSSIBLE DUE TO LACK OF CONTACT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364349 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Death