BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 6162548 · Received December 9, 2016

    Report

    Report Number
    3008973940-2016-01001
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    August 7, 2014
    Report Date
    September 15, 2016
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE THE ATRIAL LEAD ENCOUNTERED ATRIUM HIGH PACING THRESHOLD. DEVICE SETTINGS WERE RE-PROGRAMMED AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS A PARTICIPANT IN THE (B)(6) CLINICAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809159 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 457445

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MDT DEVICE