BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBD

    MDR report key: 2954549 · Received February 11, 2013

    Report

    Report Number
    9614453-2013-00481
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    MEDTRONIC S.A. (SMO)
    Product Code
    DXY
    PMA / PMN Number
    P990001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE FOLLOW UP, THE DEVICE SHOWED UNDERSENSING AND PACING/SENSING DIFFICULTY. THE SENSITIVITY HAD ALREADY BEEN INCREASED. FURTHER INVESTIGATION WILL BE CONDUCTED. 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
    57889 TBD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC S.A. (SMO) T20A1U

    Patients

    Seq Age Sex Outcome Treatment
    1