BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3142878 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08549
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 8, 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
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, LOT# L72771, IMPLANTED: (B)(6) 1999, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED ¿A LOT OF PAIN.¿ THE PATIENT HAD BEEN RECEIVING THERAPY BUT IT WAS INDICATED IT WAS NO LONGER WORKING. AN MRI WAS PLANNED TO CHECK THE PUMP TO SEE IF IT WAS WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243143 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1