BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2964614 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02736
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    January 22, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S CATHETER BROKE. A NEW SPINAL CATHETER SEGMENT WAS SPLICED TO THE EXISTING PUMP SEGMENT. PRIOR TO SURGERY, THE PATIENT WAS RECEIVING LESS THAN 50% THERAPY RELIEF, BUT WAS DOING WELL POST-OPERATIVELY. THE DRUG USED IN THIS SYSTEM WAS LIORESAL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THE CATHETER WAS REPLACED ON (B)(6)-2013 BECAUSE ¿THE LINE GOING INTO THE SPINE AREA HAD BROKEN AND SEPARATED.¿ IT WAS STATED THE CATHETER WAS "NOT FUNCTIONING.¿ IT WAS ALSO REPORTED THE CATHETER "WAS BROKEN FOR A LONG TIME BECAUSE HE STARTED TO SEIZURE.¿ IT WAS NOTED THE PATIENT ¿HAD SEIZURES ANYWAY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69097 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention