BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2983565 · Received February 28, 2013

    Report

    Report Number
    3007566237-2013-00633
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 1, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PHYSICIAN PROGRAMMER: MODEL 8840, SERIAL# UNKNOWN, IMPLANTED:NA, EXPLANTED:MA. CATHETER: MODEL 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CATHETER REVISION WAS DONE DUE TO CATHETER OCCLUSION. IT WAS NOTED THAT "IT KEPT GOING UP," IT WAS NOT NOTED WHAT THIS WAS REFERRING TO. A DYE STUDY WAS DONE, "A COUPLE WEEKS AGO," SHOWED HE WASN'T "GETTING ANY FLOW." IT WAS ALSO NOTED THAT THE DOES WAS ADJUSTED TO A "SMALL ENOUGH" DOSE BECAUSE THE PATIENT HAD "A COUPLE OF STROKES ALREADY AND WENT THROUGH WITHDRAWAL," BUT IT WAS NOT REPORTED WHEN THESE EVENT OCCURRED. THE DEVICE SYSTEM WAS USED TO INFUSE MORPHINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS REPLACED WITH NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88236 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention