BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3221219 · Received July 11, 2013

    Report

    Report Number
    3004209178-2013-11625
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    June 15, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    PRODUCT ID: 8780 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (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 CATHETER WAS RECEIVED IN TWO SEGMENTS WITH AN UNUSUAL BEND IN SEGMENT TWO IN AN AREA ONE CM FROM ITS DISTAL END. 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 AND HELD THERE, A KINK WOULD OCCUR THAT RESULTED IN AN OCCLUSION. ANALYSIS OF THE CATHETER BODY REVEALED THE KINK CAUSED THE INNER LUMEN TO OCCLUDE. THE SC CONNECTOR HAD A TEAR IN THE SEAL NEAR THE GUIDE RING.

    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, THE PATIENT EXPERIENCED SPASTICITY THAT REMAINED OR GOT WORSE FOLLOWING A PUMP AND CATHETER REPLACEMENT IN (B)(6) 2013. A SEROMA FORMED IN THE PUMP POCKET LEADING TO THE EXPLORATION OF THE SYSTEM ON (B)(6) 2013. THE PHYSICIAN OPENED THE PUMP POCKET DUE TO THE SEROMA THAT HAD FORMED. THE SEROMA WAS DRAINED. UPON DISCONNECTING THE PUMP AT THE SUTURELESS CONNECTOR SITE, HE DISCOVERED A LACK OF CEREBROSPINAL FLUID FLOW (CSF) AND DECIDED TO INVESTIGATE THE CATHETER FOR ISSUES. THE PHYSICIAN THEN PROCEEDED TO MAKE A SPINAL INCISION WHERE HE DISCOVERED A PROMINENT KINK IN THE CATHETER IMMEDIATELY PROXIMAL TO THE ANCHOR. AFTER THE PHYSICIAN STRAIGHTENED THE KINK, CSF FLOW OCCURRED. A REVISION OF THE CATHETER WAS PERFORMED ON (B)(6) 2013. PATIENT STATUS WAS ALIVE, NO INJURY, NO ADVERSE EVENT. THE PUMP WAS DELIVERING GABLOFEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT STILL HAS SWELLING SINCE THE PUMP IMPLANT. THE PATIENT HAD A SECOND OPERATION A MONTH OR TWO LATER TO FIX A "KINKED HOSE". THE HCP RECOMMENDED PUTTING A WRAP ON IT TO KEEP PRESSURE. IT HAS BEEN FIVE MONTHS AND IT WAS STILL SWOLLEN. THEY WERE NOT GETTING ANY RESULTS WITH THE WRAP. THE PATIENT WAS SEEKING A PHYSICIAN TO MANAGE THEIR CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319752 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention