BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3963677 · Received July 29, 2014

    Report

    Report Number
    3004209178-2014-13623
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, IMPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A CATHETER REVISION, THEY WERE GOING TO HOOK UP THE PUMP SEGMENT TO THE SPINAL SEGMENT AND THE COLLET FELL OFF OF THE CONNECTOR. THE HEALTHCARE PROFESSIONAL (HCP) TRIMMED APPROXIMATELY 16 CM FROM THE CATHETER, WHICH INCLUDED THE CONNECTOR THAT WAS PRE-ATTACHED. A REVISION KIT WAS OPENED AND THEY USED THE CONNECTOR PIECE TO REPLACE THE PIECE THAT BROKE. THE PUMP SEGMENT AND THE SPINAL SEGMENT WERE CONNECTED. THE PUMP CONTAINED GABLOFEN (BACLOFEN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442337 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00021 YR