BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2914482 · Received January 14, 2013

    Report

    Report Number
    3004209178-2013-00577
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    December 20, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8711, LOT# N094765013, IMPLANTED: 2008 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS REPLACED DUE TO A CATHETER BREAK AT THE DISTAL SEGMENT AND LEAK. A DYE STUDY WAS PERFORMED ON (B)(6) 2012 FOLLOWING SYMPTOMS OF BACLOFEN WITHDRAWAL. SYMPTOMS INCLUDED SEIZURES AND UNDERDOSE SYMPTOMS OF INCREASED SPASTICITY. THE DYE STUDY REVEALED A LEAK IN THE CATHETER AND ALSO AT THE CONNECTOR SITE IN BACK. THE CATHETER WAS PARTIALLY REMOVED AND A NEW CATHETER IMPLANTED ON (B)(6) 2012. THE PATIENT WAS WITH INJURY AT THE TIME OF THE REPORT. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN 500MCG/ML AT 109MCG/DAY. 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
    19873 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention