BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3396550 · Received October 9, 2013

    Report

    Report Number
    3004209178-2013-17721
    Event Type
    Injury
    Date Received
    October 9, 2013
    Report Date
    September 23, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8596SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8835, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT AT THE PUMP REFILL APPOINTMENT ON (B)(6) 2013, 35 CC OF MEDICATION WAS WITHDRAWN FROM THE PUMP; 4.2 CC WAS EXPECTED. IT WAS DETERMINED THAT THE PUMP WAS FLIPPED. FOLLOWING THE REVISION, THE PATIENT HAD ADEQUATE PAIN RELIEF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CATHETER REVISION WAS DONE (B)(6) 2013 DUE TO THE CATHETER BEING SPLIT AT THE SPINE. THEY TRIMMED THE PIECE THAT WAS KINKED. THE PUMP WAS DELIVERING MORPHINE. IT WAS LATER REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING AN INCREASE IN PAIN. THE CATHETER WAS SPLICED DURING THE REVISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511321 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention