BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3060401 · Received April 16, 2013

    Report

    Report Number
    3004209178-2013-06327
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 18, 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

    PRODUCT ID: 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8596SC LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS POTENTIALLY SCARRING ISSUES ON THE OLD CATHETER AND A NEW CATHETER WAS USED AS A REPLACEMENT. IT WAS LATER CLARIFIED THAT THE PHYSICIAN BELIEVED EXCESSIVE SCARRING ON THE CATHETER IN THE INTRATHECAL SPACE MIGHT HAVE BEEN DETECTED DURING A COMPUTERIZED TOMOGRAPHY (CT) SCAN AND THEREFORE IT WAS DECIDED TO REPLACE THE CATHETER. THE PATIENT SYMPTOMS AND CONDITION WERE REPORTED AS UNKNOWN. THE DEVICE SYSTEM DELIVERED BACLOFEN. 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
    161925 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention