BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3073549 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06791
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    March 27, 2013
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8731, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER HAD DISLODGED. THE CATHETER WAS REVISED AND A NEW DISTAL SECTION OF THE CATHETER WAS IMPLANTED. THIS DEVICE SYSTEM DELIVERED GABLOFEN. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED SYMPTOMS OF WITHDRAWAL; FEVER, ITCHING, AND GENERAL DISCOMFORT. TROUBLESHOOTING DONE BY THE PHYSICIANS LET THEM TO BELIEVE THAT THE CATHETER WAS NOT IN THE INTRATHECAL SPACE. THE PATIENT WAS BELIEVED TO BE DOING WELL FOLLOWING THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175324 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention