BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 DR

    MDR report key: 2811108 · Received October 31, 2012

    Report

    Report Number
    2647346-2012-01766
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) OR HAD AN ELECTRICAL RESET. IT WAS ALSO REPORTED THAT THE PATIENT IS PROGRAMMED TO VVI 65PPM, BUT WAS VVIR DUE TO ATRIAL FIBRILLATION. IT WAS FURTHER REPORTED THAT IF THE DEVICE IS NOT AT ERI, THE DEVICE WILL BE REPROGRAMMED AND PATIENT FOLLOWED AS NORMAL. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention 4965 X2 IMPLANTABLE PACING LEADS