BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 6009313 · Received October 6, 2016

    Report

    Report Number
    3008973940-2016-00844
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    July 6, 2016
    Report Date
    July 6, 2016
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED A P-WAVE AMPLITUDE MEASUREMENT ISSUE.

    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 ONE WEEK POST IMPLANT OF THE ATRIAL, THERE WAS UNDERSENSING OF THE P-WAVE AND CAPTURE FAILURE AT MAXIMUM OUTPUT. CHEST X-RAY SHOWED OBVIOUS DISLODGEMENT. THE LEAD WAS A REVISED AND 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
    657220 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R