BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4200481 · Received October 24, 2014

    Report

    Report Number
    3004209178-2014-20344
    Event Type
    Injury
    Date Received
    October 24, 2014
    Report Date
    October 1, 2014
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD INCREASED PAIN STARTING THE LAST TWO WEEKS THAT WAS "UNBEARABLE". THE PATIENT HAS "TESTING" PERFORMED AND THEY FOUND A SMALL LEAK IN THE CATHETER. THE PATIENT ALSO HAD A MYELOGRAM PERFORMED THE DAY BEFORE YESTERDAY. THE PATIENT HAD AN APPOINTMENT WITH A SURGEON TO SET UP A SURGERY ON "THE VERTEBRAE THAT [WAS] A PROBLEM ON THE PATIENT'S BACK". THE PATIENT THEN HAD A "LARGE SPINAL HARDWARE CASE" AND THE HEALTHCARE PROFESSIONAL (HCP) REPAIRED THE CATHETER BY EXCISING THE PIN HOLE AREA OF THE CATHETER NEXT TO THE ANCHOR. A PIN CONNECTOR WAS UTILIZED TO PUT THE PIECES BACK TOGETHER. THE PATIENT DOSE WAS NOT CHANGED. THE PUMP AREA WAS NOT ACCESSED AND THE HCP DID NOT TOUCH THE PUMP AS THE PATIENT WAS IN A PRONE POSITION. THE PUMP WAS USED TO DELIVER SUFENTA, MORPHINE AND TWO OTHER UNKNOWN DRUGS. THE RESOLUTION OF THE EVENT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678830 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention