BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6107147 · Received November 16, 2016

    Report

    Report Number
    3004209178-2016-24181
    Event Type
    Injury
    Date Received
    November 16, 2016
    Report Date
    November 16, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169100831
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURERS REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING MORPHINE (UNKNOWN DOSE AND CONCENTRATION) VIA AN IMPLANTABLE INFUSION PUMP. INDICATION FOR USE WAS UNKNOWN. IT WAS REPORTED ON (B)(6) 2016 THAT THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS. A CATHETER REVISION OCCURRED WHERE IT WAS NOTED THAT THE CATHETER HAD DISCONNECTED. AFTER THE CATHETER REVISION THE PATIENTS WITHDRAWAL SYMPTOMS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757493 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169100831

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention