BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3458746 · Received November 8, 2013

    Report

    Report Number
    3004209178-2013-20467
    Event Type
    Injury
    Date Received
    November 8, 2013
    Report Date
    October 22, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-2381-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8731SC, SERIAL# UNKNOWN, EXPLANTED: 2013 (B)(6); PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED PUMP REVEALED NO ANOMALY NORMAL DEVICE FUNCTION. RETURNED FOR ANALYSIS WAS ALSO A PARTIAL CATHETER PROXIMAL SEGMENT. ANALYSIS OF THE CATHETER REVELAED SC CONNECTOR/CORING-TEARS-CUTS IN SEAL.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: PATIENT OUCOME: IT WAS LATER REPORTED THAT PATIENT WAS FINE AND OKAY AT HOME. THERAPY WAS SUCCESSFUL AGAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD EXPERIENCED SYMPTOMS OF HEADACHE AND PAIN. THEY CHECKED THE PUMP LOGS AND INDICATED THAT INTRA-OPERATIVE TESTS WERE DONE TWICE WITH ¿CONTRAST MEDICAMENT¿ TO CHECK LEAKS IN THE CATHETER. THE PUMP CONNECTOR WAS STATED TO BE LEAKING AND TO HAVE BEEN MIGRATED/DISLODGED. PATIENT UNDERWENT A REVISION WHEREIN THE PUMP AND PUMP SEGMENT WERE REPLACED. DRUG DELIVERED VIA THE DEVICE WAS BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578386 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention