BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3812825 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-09024
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 22, 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE COMPLICATIONS WITH THE CATHETER. A COUPLE WEEKS AFTER INITIAL IMPLANT, IT WAS DISCOVERED THAT THE PATIENT'S CATHETER WAS "TWISTED" AND THE PATIENT WENT BACK IN FOR A REVISION SURGERY ON 2014 (B)(6). THE PUMP WAS USED TO INFUSE BACLOFEN AND MORPHINE. ACCORDING TO MANUFACTURE DEVICE REGISTRATION, THE ORIGINAL CATHETER WAS REPLACED WITH A NEW CATHETER ON DATE OF REVISION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER. THE PUMP WAS IMPLANTED DUE TO "CAR ACCIDENTS." AFTER THE PUMP AND CATHETER WERE IMPLANTED, THE PATIENT NEEDED TO HAVE A CATHETER REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290727 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Required Intervention