BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3200234 · Received July 1, 2013

    Report

    Report Number
    3007566237-2013-01291
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    December 4, 2008
    Report Date
    July 28, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2006-(B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A MOTOR STALL AT 12:11 AND IT RECOVERED AT 12:43. THE CAUSE OF THE STALL WAS UNKNOWN. THE DRUG IN THE PUMP WAS MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300007 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR