BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6325481 · Received February 13, 2017

    Report

    Report Number
    3004209178-2017-03672
    Event Type
    Injury
    Date Received
    February 13, 2017
    Report Date
    April 4, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169508156
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER ON 2017-MAR-08 REVEALED CORING / TEARS / CUTS IN THE SEAL OF THE SUTURELESS CATHETER (SC) CONNECTOR; MET LEAK CRITERIA PER NDHF1162-113599. ANALYSIS ALSO REVEALED DARK RESIDUE IN THE DISPENSING HOLES OF THE CATHETER BODY THAT WAS RELATED TO THE EVENT. UNDER MICROSCOPE INSPECTION, INDENTS AND CIRCULAR CORING COULD BE SEEN IN THE BOTTOM OF THE CUP OF THE SC CONNECTOR WHICH WAS CONSISTENT WITH THE INNER DIAMETER OF THE TIP OF THE OUTLET PORT OF THE PUMP. PRESSURE TESTING IN THE LAB SHOWED THE SC CONNECTOR TO BE LEAKING, MOST LIKELY DUE TO THE CORING THAT WAS SEEN. ALSO, DARK FOREIGN MATERIAL WAS SEEN IN THE MOST PROXIMAL OF THE DISPENSING HOLES OF SEGMENT 3 AS RECEIVED. WHEN INITIALLY TESTED FOR PATENCY, AN OCCLUSION WAS SEEN IN THE MOST PROXIMAL OF THE DISPENSING HOLES OF THE RETURNED SEGMENT, BUT THE OCCLUSION WAS EASILY BROKEN LOOSE. AFTER DECONTAMINATION THE DARK FOREIGN MATERIAL WAS NO LONGER IN THE MOST PROXIMAL SET OF DISPENSING HOLES, BUT THE CATHETER WAS STILL DISCOLORED IN THIS AREA. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: CATHETER. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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. THE PREVIOUSLY APPLIED CONCLUSION CODE IS NO LONGER APPLICABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING DILAUDID (10 MG/ML AT AN UNKNOWN DOSE) VIA AN IMPLANTED PUMP. THE PATIENT¿S MEDICAL HISTORY INCLUDED LUMBAR RADICULOPATHY. THE INDICATION FOR PUMP USE WAS NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME. IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF EFFICACY OVER TIME. A DYE STUDY WAS SCHEDULED, BUT THEY WERE UNABLE TO ASPIRATE THE CATHETER VIA THE CAP (CATHETER ACCESS PORT) SO IT WAS CANCELED. THE PATIENT WAS TAKEN TO SURGERY ON (B)(6) 2017 AND THEY WERE UNABLE TO ASPIRATE THE CATHETER VIA THE CAP INTRAOPERATIVELY. THE EXISTING CATHETER WAS REMOVED AND REPLACED WITH A NEW CATHETER. THE ISSUE WAS RESOLVED. THE PATIENT STATUS WAS REPORTED AS ¿ALIVE ¿ NO INJURY¿. THE ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTOR THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE WAS NOTED AS ¿NA¿.

    Description of Event or Problem · 1

    THE CATHETER WAS RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109623 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169508156

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention