BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1992705 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02996
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    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

    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. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED AND ANALYZED. PRIMARY ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. 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. IT WAS FURTHER REPORTED THAT THE LEADS WERE BOTH FRACTURED AND THE PATIENT DID NOT NEED THE DEVICE ANY LONGER. THE LEADS WERE THEN CAPPED AND THE DEVICE WAS REMOVED. NO REPLACEMENT SYSTEM WAS IMPLANTED. 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 Hospitalization| O| R (B)(4) IMPLANTABLE PACING LEAD