BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2841786 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10615
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 26, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. PATIENT REPORTED THAT HER PUMP FELL OUT THREE TIMES. THE PATIENT HAD THREE SURGERIES TO HAVE THE PUMP FIXED BECAUSE THREE DIFFERENT THINGS THAT HAPPENED, THE FELL OUT, THE KINK AND THE THIRD ONE THE PATIENT DID NOT REMEMBER. THE PATIENT SAID THAT THE PUMP WAS EXPLANTED. THE PATIENT WAS INQUIRING ABOUT GETTING A NEW PUMP FOR PAIN, NOT MS THIS TIME. IN THE PAST THE PATIENT NEVER HAD A CATHETER DYE STUDY, HER PHYSICIAN SAID IT WAS DANGEROUS TO HAVE THE TEST. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A RETURN OF SYMPTOMS AND THAT HER THERAPY ONLY WORKED FOR A WHILE. IT WAS INDICATED THAT THE PATIENT RECEIVED 2 BOLUSES AT THE PHYSICIAN'S OFFICE BUT SHE HAD NO RELIEF. THE SPECIFIC DATE OF EVENTS WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. THE PATIENT HAD HER FIRST CATHETER REVISION DUE TO A CATHETER KINK. THE OUTCOME OF THE PATIENT WAS NOT PROVIDED. THE DRUG DELIVERED VIA PUMP WAS LIORESAL ACCORDING TO THE MANUFACTURER DEVICE REGISTRY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention