BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2231103 · Received August 26, 2011

    Report

    Report Number
    3007566237-2011-06955
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    January 1, 2010
    Report Date
    August 10, 2011
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A CATHETER REVISION WAS BEING CONDUCTED; AND THE PATIENT'S INTRATHECAL BACLOFEN CONCENTRATION WAS GOING TO CHANGE FROM 2000 MCG/ML TO 500 MCG/ML. THE PUMP WAS PLANNED TO BE REMOVED IN REGARDS TO REFILLING. IT WAS LATER REPORTED THAT A NEW CATHETER WAS PLACED, AS THE OTHER CATHETER WAS DETERMINE AS NOT BEING IN THE "INTRATHECAL PLACE". THE PATIENT WAS NOT RECEIVING RELIEF FOR ABOUT (B)(6); AND IT WAS NOTED THAT A PHYSICIAN COULD NOT ASPIRATE. THE PATIENT WAS OPENED UP AT THE SPINE IN REGARDS TO THE CATHETER REPLACEMENT PROCEDURE. A PUMP RINSE WAS PERFORMED IN ORDER TO CLEAR THE 2000 MCG/ML DRUG, AS THE PUMP WAS REFILLED WITH A DRUG CONCENTRATION OF 500 MCG/ML. THE PATIENT WAS NOTED AS STILL BEING IN THE HOSPITAL IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention CATHETER: MODEL 8709SC, LOT# N237722005| IMPLANTED:| EXPLANTED: