BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1074865 · Received June 20, 2008

    Report

    Report Number
    2182207-2008-03097
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Report Date
    December 1, 2006
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION WHICH COVERS A 3-YEAR RETROSPECTIVE REVIEW OF EVENTS REPORTED BY CONSUMERS, BETWEEN 2004 AND 2007 (INCLUSIVE). THIS EXEMPTION WAS GRANTED TO SATISFY MEDTRONIC'S MDR OBLIGATIONS FOR ANY PREVIOUSLY UNREPORTED SERIOUS INJURY, DEATH AND MALFUNCTION EVENTS FOUND DURING THIS REVIEW. THIS MEDWATCH REPORT REPRESENTS 2 UNREPORTED MALFUNCTION EVENTS FOR MODEL DDB PROGRAMMER, 1 MALFUNCTION EVENT FOR MODEL 8627-10, 15 MALFUNCTION EVENTS FOR MODEL DDB PUMP, 1 MALFUNCTION EVENT FOR MODEL DDB CATHETER, 1 MALFUNCTION EVENT FOR MODEL 863740, 2 MALFUNCTION EVENTS FOR MODEL 8637, 1 MALFUNCTION EVENT FOR MODEL 8627L18 AND 1 MALFUNCTION EVENT FOR MODEL 862718 FOR THE ABOVE TIME PERIOD (ALL PRODUCT CODE LKK). THIS TOTAL INCLUDES THE EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED VOLUME DISCREPANCIES WERE ENCOUNTERED; 6.0 ML WAS ASPIRATED WHEN 3.2 ML WAS EXPECTED.

    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 UNK CATHETER MODEL CATHETER LOT #UNK IMPLANTED| EXPLANTED| EXPLANTED| PROGRAMMER MODEL 8840 LOT # UNK IMPLANTED| EXPLANTED| EXPLANTED| PROGRAMMER MODEL 8840 LOT # UNK IMPLANTED| CATHETER MODEL CATHETER LOT #UNK IMPLANTED