BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3180034 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-10641
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    PRODUCT ID 8835, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT ONLY A PARTIAL PORTION OF THE 8709 CATHETER SERIAL #(B)(4), THE DISTAL PORTION, WAS RETURNED FOR ANALYSIS. ANALYSIS OF THE CATHETER REVEALED A HOLE IN THE CATHETER BODY. AN AREA THAT APPEARED TO BE A DEEP ABRASION WAS FOUND AT 43.7 TO 44.2CM FROM THE DISTAL TIP OF THE RETURNED PORTION OF THE CATHETER. A TINY AMOUNT OF LEAK WAS SEEN IN THIS AREA, WHICH MEANT THAT THE DEEP ABRASION WENT THROUGH THE INNER LUMEN. THE ABRASION MAY HAVE BEEN CAUSED BY A CERTAIN PART OF THE ANATOMY OF THE PATIENT RUBBING ON THE CATHETER WHILE THE CATHETER WAS IMPLANTED IN THE INTRATHECAL SPACE. A MINOR OBSERVATION WAS THAT BOTH WINGS OF THE ANCHOR WERE MISSING AND APPEARED TO HAVE BEEN CUT AWAY. THIS MOST LIKELY OCCURRED AT EXPLANT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT OUTCOME WAS REPORTED AS "RESOLVED WITHOUT SEQUELAE" RESOLVED DATE: (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCREASED PAIN IN THE LEFT ARM AND NECK. THIS WAS BELIEVED TO LIKELY BE SECONDARY TO A NEW METASTASIS. ON (B)(6) 2013, A CATHETER ACCESS PORT CONTRAST STUDY SHOWED A CATHETER FRACTURE BUT THE FLOW OF DYE INTO THE INTRATHECAL SPACE WAS ACCEPTABLE. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID, BUPIVACAINE AND CLONIDINE AND BACLOFEN. IT WAS LATER REPORTED THAT THE CATHETER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281570 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR Required Intervention