BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2885241 · Received December 26, 2012

    Report

    Report Number
    3004209178-2012-12208
    Event Type
    Injury
    Date Received
    December 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-2380-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): FINAL ANALYSIS OF THE PUMP FOUND NO ANOMALIES. FINAL ANALYSIS OF THE PROXIMAL SEGMENT OF THE CATHETER FOUND A WELL-DEFINED INDENT IN THE CUP OF THE SC CONNECTOR WITH AT LEAST 90% OF THE CIRCLE LOCATED IN THE WHITE SILICON MATERIAL. IT WAS NOTED THAT THIS MAY HAVE BEEN THE CAUSE OF THE OCCLUSION. FINAL ANALYSIS OF THE DISTAL SEGMENT OF THE CATHETER FOUND NO SIGNIFICANT ANOMALIES, BUT IT HAD BEEN RETURNED IN SEGMENTS.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, 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.

    Description of Event or Problem · 1

    THE PATIENT HAD LESS THAN 50% THERAPY RELIEF. THE PUMP HAD VOLUME DISCREPANCIES. IT WAS SUSPECTED THAT THERE WAS AN OCCLUSION INSIDE OF THE SUTURELESS CONNECTOR (SC) PIECE OF THE CATHETER. IN SURGERY, THE SURGEON DISCONNECTED THE SC FROM THE PUMP AND THERE WAS NO SPONTANEOUS FLOW. HE THEN DISCONNECTED THE SC FROM THE CATHETER AND THERE WAS IMMEDIATELY SPONTANEOUS FLOW FROM THE CATHETER. IT WAS SUSPECTED THAT THERE WAS AN OCCLUSION IN THE INNER TUBING OF THE SC SEGMENT OF THE CATHETER. THE SURGEON PUT SALINE IN THE PUMP CONNECTOR INTERFACE AND WATCHED FOR IT TO PASSIVELY MOVE THROUGH THE CATHETER, WHICH IT DID NOT. HE THEN PUT A SYRINGE INTO THE INTERFACE AND FLUSHED SALINE THROUGH. WITH PRESSURE, SOMETHING SEEMED TO GIVE AND THE FLOW INCREASED. THE PHYSICIAN SUSPECTED THAT MAYBE THE CHILD HAD HIGH PROTEIN COUNTS THAT WERE CAUSING THIS BUILD UP. THE ENTIRE SYSTEM WAS REMOVED PER THE FAMILY'S REQUEST. THE PUMP WAS THEN SET TO MAX FLOW RATE TO ENSURE THAT THERE WAS IN FACT FLOW COMING FROM THE PUMP. THE PUMP WAS EMPTIED TO REVEAL A VOLUME DISCREPANCY; EXPECTED VOLUME 13.7ML; ACTUAL VOLUME 18.5ML. THE PATIENT WAS GOING TO CONTINUE TO BE MANAGED WITH ORAL MEDICATION. THERE WAS REPORTED TO BE NO PATIENT INJURY. THE PATIENT RECOVERED WITHOUT SEQUELA. THE DEVICE SYSTEM WAS DELIVERING LIORESAL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS A PSEUDOMENINGOCELE AT THE POCKET, THOUGH THERE WAS NO EVIDENCE OF TRANSCUTANEOUS CEREBROSPINAL FLUID LEAK. IT WAS NOTED THAT THE PSEUDOMENINGOCELE WAS "NOT NECESSARILY AN UNUSUAL FINDING IN A CHILD IN HER POSITION".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00006 YR Required Intervention