BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5514543 · Received March 21, 2016

    Report

    Report Number
    3004209178-2016-05022
    Event Type
    Injury
    Date Received
    March 21, 2016
    Report Date
    March 21, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE: CATHETER MEDTRONIC, INC.

    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 HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE REGARDING PATIENT RECEIVING MORPHINE (UNKNOWN CONCENTRATION) AT AN UNKNOWN RATE FOR SPINAL PAIN. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATION WERE NOT REPORTED. THE CATHETER WAS COILED UP IN THE BACK INCISION AND NO LONGER INTRATHECAL. THE PATIENT'S PAIN RETURNED. A CATHETER REVISION TO PUT IT BACK INTRATHECAL WAS PLANNED, BUT NOT YET SCHEDULED. THE PATIENT WAS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169322 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention