BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3203566 · Received July 3, 2013

    Report

    Report Number
    3004209178-2013-04517
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    September 25, 2012
    Report Date
    September 25, 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
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PUMP WAS FLOATING IN THE POCKET. THE UNIT ITSELF WAS ¿NOT SEWN DOWN.¿ IT MAY HAVE NEEDED A REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304987 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention