BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1800134 · Received August 10, 2010

    Report

    Report Number
    3007566237-2010-05999
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 12, 2010
    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 REPORTED THAT A CRITICAL ALARM WAS OCCURING AND CONFIRMED BY TELEMETRY. THE ALARM WAS DUE TO ZERO ML RESERVOIR VOLUME REACHED; THE PT'S PUMP HAD RUN DRY. THE PT WAS SCHEDULED FOR A CATHETER REVISION THE NEXT DAY BECAUSE THE HCP WAS UNABLE TO ASPIRATE FROM THE CATHETER ACCESS PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| IMPLANTED:| CATHETER: MODEL CATHETER, LOT# UNK