BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 5711133 · Received June 9, 2016

    Report

    Report Number
    2182208-2016-01432
    Event Type
    Injury
    Date Received
    June 9, 2016
    Date of Event
    April 2, 2015
    Report Date
    February 29, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY # GEO EVENT DESCRIPTION: IT WAS REPORTED THAT THE PACING IMPEDANCE OF THIS LEAD HAD A PROGRESSIVE ELEVATION OF IMPEDANCE: 2013 = 465; 2014 = 1056; END-2014 = 1700; (B)(6) 2015> 2000. THRESHOLD NORMAL 0.6 / 0.5; SENSING NORMAL 25 MV. SINCE THE PACING IMPEDANCE WAS HIGH (> 2000 OHMS) AND A TAVI PROCEDURE IS PLANNED, IT WAS DECIDED TO REPLACE THIS LEAD. THE LEAD WAS EXTRACTED WITH EXTRACTION WIRE ON (B)(6) 2015. PRELIMINARY GEO ASSESSMENT: NO STD. SERIAL NUMBER ASSOCIATED DEVICE UNKNOWN. EVENT DESCRIPTION SUGGESTS PERSISTENT IMPEDANCE INCREASE. PRELIMINARY GEO CONCLUSION: SUSPECT LEAD OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED GRADUAL RISE OF IMPEDANCE AND HIGH IMPEDANCE VALUES. THE LEAD WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367671 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R