BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202913 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00991
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    November 26, 2008
    Report Date
    March 29, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 1999-(B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    A PROBLEM WAS REPORTED. HCP REPORTED A PROBLEM RELATED TO A PUMP. A MOTOR STALL WAS REPORTED. THE MOTOR STALL WAS CONFIRMED IN ATTENTION DIALOGUE BOX. MOTOR STALL RECORDED IN EVENT LOGS WITH MOTOR STALL RECOVERY RECORDED. COMPANY REPRESENTATIVE REPORTED MOTOR STALL RECOVER IN NO MORE THAN 20-30 MINUTES. MOTOR STALL CAUSED BY HCP USING MAGNET WHEN TRYING TO DO TELEMETRY TO THE PUMP. NO SYMPTOMS REPORTED. NO CONSEQUENCES TO THE PATIENT WERE REPORTED AT THE TIME. IF ADDITIONAL INFORMATION IS RECEIVED A REPORT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302352 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR