BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1862529 · Received October 8, 2010

    Report

    Report Number
    2649622-2010-09933
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    April 26, 2010
    Report Date
    February 28, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTION: ADDED CORRECTION TO EVENT DESCRIPTION TO NOTE PATIENT WAS HAVING DIAPHRAGMATIC STIMULATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POLARITY SWITCH, 251 LOW IMPEDANCE PACES, NO DIAPHRAGMATIC STIMULATION PRESENT, AND VENTRICULAR HIGH RATE EPISODES OCCURRED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. EDIT (B)(6) 2010: CORRECTION: THE PATIENT DID HAVE DIAPHRAGMATIC STIMULATION. UPDATE: THE DEVICE REMAINS IN USE. IT WAS FURTHER REPORTED THERE WAS LOW IMPEDANCE AND OVERSENSING. THE LEAD 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
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Other 4076-45 IMPLANTABLE PACING LEAD| 4076-45 IMPLANTABLE PACING LEAD