BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3071462 · Received April 22, 2013

    Report

    Report Number
    3007566237-2013-01385
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 26, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASPIRATION ISSUE OCCURRED. NINE MILLILITERS OF MORPHINE WERE EXPECTED TO HAVE BEEN WITHDRAWN FROM THE RESERVOIR, BUT THERE WAS 0 MILLILITERS OF MEDICATION ASPIRATED. THE HEALTHCARE PROFESSIONAL WAS REVIEWING THE PATIENT AND PUMP RECORDS, LOOKING FOR VOLUME RELATED DISCREPANCIES, BUT NOTHING WAS REPORTED AS OF THIS REPORT DATE. THE PATIENT WAS TO BE SEEN BY THE HEALTH CARE PROVIDER PRIOR TO THE NEXT PLANNED REFILL DATE. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172109 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1