BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2841849 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10618
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 25, 2012
    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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING HEADACHES AND NAUSEA. THE PATIENT'S CATHETER HAD A LEAK NOT LONG AFTER THE PUMP WAS IMPLANTED. THE CATHETER WAS REVISED (B)(6) 2012. THE PATIENT HAD ONGOING SYMPTOMS OF NAUSEA AND VOMITING DUE TO BEING SENSITIVE TO THE DRUG. THE DRUGS IN THE PUMP WERE CLONIDINE, BUPIVACAINE, AND MORPHINE. IT WAS LATER REPORTED THAT THE SPINAL SEGMENT OF THE CATHETER FELL OUT OF THE SUBARACHNOID SPACE AND WAS LYING COILED IN THE SUBCUTANEOUS TISSUE. A NEW SPINAL CATHETER WAS INSERTED AND SLICED TO THE OLD CATHETER'S PROXIMAL SEGMENT. THE PATIENT RECOVERED AND WAS RECEIVING EFFECTIVE THERAPY. IT WAS NOTED THE DRUGS IN THE PUMP WERE CLONIDINE AND BUPIVACAINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention