BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3253222 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12464
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    July 8, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-2381-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8731SC, SERIAL# UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A KINK IN THE CATHETER AND A DISCONNECTION AT THE PUMP CONNECTOR. A DYE STUDY AND ROTOR STUDY WERE PERFORMED AS WELL AS X-RAYS AND PUMP LOGS CHECKED. THE CATHETER CONNECTOR WAS REPLACED AND IT WAS NOTED THAT THE ISSUE WAS RESOLVED. IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS. PATIENT STATUS AT THE TIME OF THE REPORT WAS NO INJURY. THE DEVICE SYSTEM DELIVERED GABLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353796 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention