BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3030631 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04469
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 4, 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
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: CATHETER MODEL 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. (B)(4). 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

    THE ANALYSIS OF THE CATHETER FOUND A TEAR IN THE SEAL NEAR THE GUIDE-RING OF THE SUTURELESS CONNECTOR BUT THE ANOMALY WAS NOT C ONSIDERED SIGNIFICANT AND DID NOT AFFECT IN-VIVO FUNCTION.

    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

    ANALYSIS OF THE CATHETER FOUND A LEAK IN THE CATHETER BODY SEEN IN THE STRAIN RELIEF-TRANSITION TUBING REGION. IT WAS DETERMINED THE LEAK AREA WAS WHERE THE POLYURETHANE LAYER BEGAN. A TEAR IN THE SEAL NEAR THE GUIDE RING OF THE SC CONNECTOR WAS ALSO FOUND. IT WAS DETERMINED THE INITIAL LEAK SEEN DURING ANALYSIS WAS NOT CAUSED BY THE CUSTOMER BUT MAY HAVE BEEN PRESENT WHEN THE CATHETER WAS IMPLANTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT COMPLAINED OF 'NO PAIN RELIEF.' THE MANAGING PHYSICIAN DID A CATHETER DYE STUDY AND SAW EXTRAVASATION AROUND THE PUMP POCKET SITE. A CATHETER REVISION WAS DONE ON THE DAY OF THE INITIAL REPORT. DURING SURGERY, THE HEALTHCARE PROVIDER (HCP) USED THE CATHETER ACCESS PORT KIT TO WITHDRAW 4ML OF CEREBRAL SPINAL FLUID. IT APPEARED THE CATHETER WAS PATENT WITHOUT ANY PROBLEMS. THE HCP THEN DECIDED TO PUSH PRESERVATIVE FREE NORMAL SALINE INTO THE SIDE PORT TO THE CATHETER TO 'LOOK FOR LEAKS.' HE NOTICED A SMALL LEAK IN THE CATHETER ABOUT 3CM FORM THE CONNECTOR. THERE WAS NO HOLE IN THE CATHETER 'ANYWHERE.' THE HCP WAS 'CONFIDENT' THE LEAK WAS A MANUFACTURING PROBLEM. A NEW PUMP SEGMENT WAS CONNECTED TO THE PUMP WITH A COLLET CONNECTION. THE DEVICE WAS USED TO INFUSE MORPHINE. 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
    133910 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention