BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3811409 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-08999
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 21, 2014
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8781, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A REPRESENTATIVE INDICATING A CATHETER KINKED. THE CATHETER WAS REPLACED. NO SYMPTOMS WERE REPORTED TO THEM. THE MEDICATION INFUSED WAS MORPHINE. ON (B)(4) 2014, INFORMATION WAS RECEIVED FROM A REPRESENTATIVE INDICATING THE PATIENT HAD BEEN HAVING LESS PAIN RELIEF. THE LOCATION OF THE CATHETER ISSUE WAS NOT SPECIFIED. THE SURGEON REMOVED AND REPLACED THE OLD CATHETER. ON (B)(4) 2014, INFORMATION WAS RECEIVED FROM A PATIENT INDICATING THAT THEIR CATHETER HAD BEEN REPLACED YESTERDAY BECAUSE IT BROKE OFF WHERE IT WAS CONNECTED TO THEIR SPINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290492 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention