BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2885149 · Received December 26, 2012

    Report

    Report Number
    3004209178-2012-12217
    Event Type
    Injury
    Date Received
    December 26, 2012
    Report Date
    November 26, 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
    CY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INCREASE IN SPASTICITY AND THEY "DID NOT SEE ANY IMPROVEMENT SINCE THEIR LAST REFILL." A DRUG RESERVOIR VOLUME DISCREPANCY WAS NOTED DURING A PUMP REFILL WHEN 22ML WAS ASPIRATED, BUT 7.1ML WAS EXPECTED. THE PATIENT'S PHYSICIANS HAD DETERMINED THAT THE "CATHETER WAS BLOCKED" AS ATTEMPTS OF BACLOFEN ASPIRATION THROUGH THE CATHETER ACCESS PORT HAD FAILED. A CATHETER REVISION WAS SCHEDULED. X-RAYS WERE PERFORMED, AND A CATHETER MISALIGNMENT WAS NOT SUSPECTED AT THE TIME OF THIS REPORT. NO INFORMATION REGARDING PATIENT OUTCOMES WERE AVAILABLE AT THE TIME OF THIS SUBMISSION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention