BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3181872 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10697
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE CATHETER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAN FLIP THE PUMP BUT THAT IT HAD NOT BEEN AN ISSUE. NO FURTHER INFORMATION WAS PROVIDED. THIS DEVICE SYSTEM DELIVERED LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. (THE PUMP FLIPPING ISSUE HAD BEEN PREVIOUSLY CAPTURED IN MANUFACTURER REPORT #3004209178-2013-02891).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282913 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1