BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1892393 · Received November 3, 2010

    Report

    Report Number
    3004209178-2010-08819
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    A PT UNDERWENT A CATHETER REVISION ON (B)(6) 2010, AS THEIR PAIN WAS NOT BEING WELL CONTROLLED. THE CATHETER TIP WAS NOTED TO BE AT THE T1 LOCATION, AND A SECTION OF THE CATHETER APPEARED FRACTURED. A DYE STUDY WITH FLUORO WAS UNABLE TO FIND THE REST OF THE CATHETER. AT THE TIME OF THE CATHETER REVISION SURGERY, WHEN THE BACK INCISION WAS OPENED, IT WAS DISCOVERED THAT THE CATHETER WAS ALSO FRACTURED AT THE ANCHOR SITE. A SMALL SECTION OF THE CATHETER WAS REMOVED, AND A PURSE STRING SUTURE WAS PLACED. A NEW SPINAL SECTION OF THE CATHETER WAS PLACED AND PINNED TO THE EXISTING CATHETER. FENTANYL (8000 MCG/ML) WAS REDUCED FROM 2932.8 MCG/DAY TO 384 MCG/DAY FOLLOWING THE REVISION PROCEDURE. IN ADDITION BUPIVICAINE (10 MCG/ML) WAS REDUCED FROM 3.66 MCG/DAY TO .48 MCG/DAY. THE PT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION OVERNIGHT. THE PT HAD RECOVERED WITH SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention CATHETER: MODEL 8709, LOT# J0056597R| IMPLANTED:| EXPLANTED: