BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3800051 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08719
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    April 15, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 8731, SERIAL# (B)(4), PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP AND ENTIRE CATHETER REPLACEMENT OCCURRED ON THE DATE OF THIS REPORT. THE CATHETER HAD MIGRATED OUT OF THE IT (INTRATHECAL) SPACE. WHILE IT WAS REPORTED THE PATIENT¿S REPLACEMENT DEVICE SYSTEM DELIVERED BACLOFEN, IT WAS NOT CLEARLY SPECIFIED IF BACLOFEN WAS BEING DELIVERED VIA THEIR PREVIOUS SYSTEM. IT WAS LATER REPORTED THAT THE CATHETER WAS ALSO FOUND TO BE HAVE BEEN NOT PATENT AND ¿OUT¿ SO THE PATIENT HADN¿T BEEN RECEIVING ANY INTRATHECAL BACLOFEN. THE PATIENT HAD NO SYMPTOMS. IT WAS FURTHER REPORTED THE PATIENT WAS NOW DOING WELL. SHE WAS AT A REHABILITATION CENTER FOR PHYSICIAN THERAPY AND THE HEALTH CARE PROVIDER (HCP) WAS SLOWLY INCREASING HER PUMP. 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
    278600 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention