BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3841327 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09852
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE CATHETER. (B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT EXPERIENCED INCREASED TONE AND DYSTONIC POSTURING. THE DISTAL CATHETER WAS OCCLUDED DUE TO AN UNKNOWN FLESH COLORED MATERIAL IN THE CATHETER ORIFICES. IT WAS IDENTIFIED DURING INTRAOPERATIVE EXPLORATION. THE ENTIRE CATHETER WAS REPLACED. THERE WERE NO CATHETER SEGMENTS LEFT IN THE PATIENT. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED SINCE IMPLANT, THE DOSE HAD TO BE SLOWLY INCREASED. THE PATIENT HAD PERIODS OF CLONUS AND WOULD THEN IMPROVE. A CATHETER REVISION WAS DONE. THE SYSTEM WAS BEING USED TO DELIVER GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319187 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention