BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3121817 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-07961
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8578, LOT# N171554006, IMPLANTED: (B)(6) 2008, PRODUCT TYPE ACCESSORY; PRODUCT ID 8 709SC, LOT# N178569008, IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, LOT# N178569008, IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A ¿POSSIBLE¿ DISLODGED, OR DISPLACED, CATHETER. THE CALLER DID NOT KNOW WHEN THE ISSUE OCCURRED BUT STATED THE MAGNETIC RESONANCE IMAGING (MRI) WAS BEING DONE TO CHECK CATHETER PLACEMENT. THE MEDICATION BEING DISPENSED WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223531 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1