BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA SR

    MDR report key: 1924584 · Received December 14, 2010

    Report

    Report Number
    6000094-2010-02277
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    April 1, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    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 BY THE PATIENT THAT THE PACEMAKER BEGAN TO MISS BEATS. THE PATIENT GOT DIFFERENT PERSPECTIVES ABOUT WHETHER THE SOURCE OF THE ISSUE WAS THE HEART OR THE PACEMAKER. THE PATIENT HAD QUESTIONS ABOUT FUNCTION AND SOUGHT CLARIFICATION. THE PATIENT ALSO COMPLAINED OF BEING LIGHT HEADED WHEN STANDING UP SLOWLY. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA SR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. SESR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other