BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA 300 DR

    MDR report key: 2131069 · Received June 16, 2011

    Report

    Report Number
    6000094-2011-01129
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 28, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW UP VISIT, THE DEVICE SHOWED A CHANGE IN OUTPUT PROGRAMMING. THE HEALTHCARE PROFESSIONAL REQUESTED THE DEVICE DATA TO BE CHECKED FOR A POSSIBLE DEVICE RESET. THE PATIENT REPORTED THAT THE DEVICE WAS NOT CHECKED NOR CHANGED FOR ANY REASONS. 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 S.A. SDR303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD