BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2943776 · Received February 5, 2013

    Report

    Report Number
    3004209178-2013-01299
    Event Type
    Injury
    Date Received
    February 5, 2013
    Report Date
    January 10, 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
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER REVEALED THE CATHETER BODY SHARP BEND IN TRANSITION TUBE AREA POSSIBLY CAUSED OCCLUSION AND CATHETER SC CONNECTOR TEAR IN SEAL, NEAR GUIDE RING. THE CATHETER WAS RECEIVED IN TWO SEGMENTS WITH AN UNUSUAL BEND IN SEGMENT 1 IN THE AREA OF THE TRANSITION TUBING, CLOSE TO THE SC CONNECTOR. TESTING SHOWED BOTH SEGMENTS TO BE PATENT AND BOTH PASSED PRESSURE TESTING. HOWEVER, IF THE CATHETER WAS CURVED INTO AN EXTREME POSITION IN THE AREA OF THE BEND NOTED ABOVE, A KINK WOULD OCCUR THAT RESULTED IN AN OCCLUSION. THERE IS OTHER UNUSUAL DAMAGE IN THE AREA OF THE BEND IN THE TRANSITION TUBING INCLUDING SLICE CUTS THROUGH THE TRANSITION TUBING THAT GO INTO THE OUTER POLYURETHANE LAYER PLUS A WORN AREA ON THE TRANSITION TUBING NEAR THAT SAME BEND. IT IS UNKNOWN HOW THE BENT AREA ACTUALLY OCCURRED BUT IT WAS DETERMINED THE CATHETER HAD TO BE STRESSED BEYOND ITS INTENDED LIMITS FOR A KINK TO RESULT IN OCCLUSION. ALSO SEEN WAS A COMPRESSED SECTION OF SEGMENT 1 FOUND 14 TO 14.5 CM FROM ITS DISTAL END. IT IS UNKNOWN HOW THIS COMPRESSED AREA OCCURRED BUT IT WAS NOT SIGNIFICANT ENOUGH TO COLLAPSE THE CATHETER AND CAUSE AN OCCLUSION OF THE INNER LUMEN.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE INITIAL ANALYSIS RESULT OF THE CATHETER WAS CODED RELIABILITY NON-CONFORMANCE. THIS TEAR IN THE SILICONE SEAL ISSUE WAS FURTHER INVESTIGATED INTERNALLY AND CONCLUDED THAT THE CORRECT CODING SHOULD BE NO SIGNIFICANT ANOMALY AND/OR EXPLANT DAMAGE. ANALYSIS OF DEVICES WITH OBSERVED TEARS IN THE SEAL NEAR THE GUIDE RING DETERMINED THAT THE ANOMALY DOES NOT AFFECT DEVICE PERFORMANCE OR ITS ABILITY TO MEET PRODUCT SPECIFICATIONS. THE TEARS IN THE SEAL MATERIAL DO NOT AFFECT THE CONNECTOR PERFORMANCE AND THEY DO NOT PREVENT THE CONNECTION FROM REMAINING PATENT OR CREATE A LEAK CONDITION. IN ADDITION, THERE ARE NO ALLEGATIONS OF EMBOLISMS DUE TO TEAR. THESE TEARS IN THE SEAL ALSO DO NOT PRESENT A PERFORMANCE ISSUE TO THE CONNECTOR IF THE CATHETER IS RECONNECTED.

    Additional Manufacturer Narrative · 1

    CORRECTED ANALYSIS: ANALYSIS FURTHER DETERMINED THAT THE TEAR IN THE SEAL NEAR THE GUIDE RING OF THE SUTURELESS CONNECTOR WAS NOT SIGNIFICANT TO THE CATHETER¿S IN-VIVO PERFORMANCE.

    Additional Manufacturer Narrative · 1

    THE PREVIOUSLY REPORTED CONCLUSION CODES WERE UPDATED.

    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 REPORTED THAT THERE WAS A VOLUME DISCREPANCY IN THE PATIENT'S PUMP. THE EXPECTED RESIDUAL VOLUME WAS 6.4ML, BUT THE ACTUAL RESIDUAL VOLUME WAS 19.0ML. IT WAS NOTED THAT THIS WAS NOT THE FIRST TIME THAT A VOLUME DISCREPANCY HAD OCCURRED, BUT THAT THE RESERVOIR WAS NEARLY FULL AT MOST OF THE PATIENT'S REFILL APPOINTMENTS. AT THE TIME OF REPORT, THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THE EVENT. ONE WEEK LATER, IT WAS REPORTED THAT AN X-RAY USING A CONTRAST MEDIUM, IOPAMIRO, WAS NOT POSSIBLE DUE TO THE PHYSICIAN'S INABILITY TO ASPIRATE THE CATHETER ACCESS PORT (CAP). THE PUMP SEGMENT OF THE CATHETER WAS THEN EXPLANTED DUE TO THE LACK OF LIQUID FLOW THROUGH IT. ONE WEEK AFTER THAT, IT WAS REPORTED THAT THERE HAD BEEN A "CATHETER CLOSURE" OR "BUCKLE" AT A POINT BETWEEN THE FIXATION TO THE PUMP AND THE INTRATHECAL SEGMENT. AT THE TIME OF REPORT, THE SYSTEM WAS WORKING PROPERLY AND THE PATIENT OUTCOME WAS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47796 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention