BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3022768 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-04278
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    THE PUMP "MAY HAVE SLIPPED" OR MOVED AROUND IN THE POCKET IN THE PAST, BUT THE REPORTER WAS "NOT ONE HUNDRED PERCENT SURE." THE DEVICE SYSTEM WAS USED TO INFUSE CLONIDINE AND BUPIVACAINE. NO OTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125347 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1