BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4232990 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21099
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    October 15, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CSF LEAK. THE PATIENT HAD MULTIPLE SURGERIES TO TRY TO REPAIR THE DURA SINCE (B)(6) 2014. THE MANUFACTUER¿S REPRESENTATIVE WAS UNSURE WHAT PORTION OF THE CATHETER, IF ANY, HAS BEEN LEFT IN PLACE. IT WAS NOTED THAT THE PUMP HAD BEEN DELIVERING FENTANYL AT MINIMUM RATE SINCE (B)(6) 2014 INTO THE POCKET. A CATHETER REPLACEMENT PROCEDURE WAS TO OCCUR. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715819 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention