BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5563474 · Received April 8, 2016

    Report

    Report Number
    3004209178-2016-07084
    Event Type
    Injury
    Date Received
    April 8, 2016
    Date of Event
    March 15, 2016
    Report Date
    May 3, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER.

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED, AND ANALYSIS FOUND CORING-TEARS-CUTS IN THE SEAL OF THE SC CONNECTOR (MEETS LEAK CRITERIA PER NDHF1162-113599). (B)(4).

    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 THE CONSUMER THROUGH A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT RECEIVING INTRATHECAL DILAUDID 10 MG/ML AT 1.350 MG/DAY. THE INDICATIONS FOR USE WERE NON-MALIGNANT PAIN AND ARACHNOIDITIS. THE PATIENT EXPERIENCED AN INCREASE IN PAIN, FLUID IN THE PUMP/AROUND THE PUMP POCKET. FLUID WAS LEAKING AT THE CATHETER CONNECTION ON THE PUMP. THE CATHETER APPEARED TO NOT BE SEATED CORRECTLY ON THE PUMP. A DYE STUDY WAS PERFORMED PRIOR TO OPENING THE PUMP POCKET. AFTER THE CATHETER WAS REMOVED FROM THE PUMP, THE CATHETER ACCESS PORT (CAP) WAS FLUSHED AND FLUID WAS OBSERVED TO BE COMING OUT OF THE BASE OF THE CATHETER CONNECTION LOCATION. THE PUMP AND PUMP SEGMENT OF THE CATHETER WERE REPLACED. THE ISSUE WAS RESOLVED. THE PATIENT'S STATUS WAS "ALIVE - NO INJURY" AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROVIDER (HCP). THE CONNECTION WAS DAMAGED, NOT PROPERLY SEATED, AND DIFFICULT TO SEPARATE FROM THE PUMP (NEEDED A TOOL). FLUID INJECTED INTO THE PUMP CATHETER ACCESS PORT (CAP) DID NOT CLEARLY ALL EXIT THE PUMP AT THE CATHETER CONNECTOR. IT WAS NOTED THAT THE PATIENT WAS NEW TO THE HCP'S OFFICE ((B)(6) 2015).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217463 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention