BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA 300 DR

    MDR report key: 1922355 · Received December 13, 2010

    Report

    Report Number
    2647346-2010-00835
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 2, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A DISCREPANCY BETWEEN THE PACING/SENSING HISTOGRAMS AND THE PACING PERCENTAGE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 300 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. SDR303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other 5076X2 IMPLANTABLE PACING LEAD