BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3011309 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-03927
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8731 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8590-1 LOT# N060037, IMPLANTED: 2006 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE MOTOR STALL RECOVERED WITHIN ONE AND A HALF HOURS OF THE MRI. THERE WERE NO SYMPTOMS RELATED TO THE MOTOR STALL. THE PATIENT WAS NOT HOSPITALIZED AND NO REPLACEMENT WAS DONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONFIRMED MOTOR STALL WAS NOTED IN THE EVENT LOGS WITH NO MOTOR STALL RECOVERY RECORDED. THE MOTOR STALL WAS CAUSED BY THE PATIENT HAVING A MAGNETIC RESONANCE IMAGING (MRI) STUDY, WHICH WAS BEING DONE DUE TO THE PATIENT'S MULTIPLE SCLEROSIS AND OTHER MEDICAL ISSUES NOT RELATED TO THE PUMP. THE PUMP WAS BEING USED TO DELIVER LIORESAL (BACLOFEN). ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113973 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1