BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1990866 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02164
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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) PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED. MANY HIGH IMPEDANCE PACES WERE NOTED ON BOTH A AND V LEADS. THERE WERE LEAD WARNINGS ON THE ATRIAL LEAD ON (B)(6) 2010 AND ON THE VENTRICULAR LEAD ON (B)(6) 2009. THERE WERE NUMEROUS SHORT DURATION AUTOMATIC ATRIAL AND VENTRICULAR HIGH RATE EPISODES, SUGGESTIVE OF NON-PHYSIOLOGIC CAUSES.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POLARITY SWITCH, INCREASING AND HIGH IMPEDANCE, NO CAPTURE, AND NO SENSING ON THE ATRIAL LEAD. THE DEVICE WAS REPROGRAMMED AND THE ATRIAL LEAD WAS DEACTIVATED. IT WAS ALSO REPORTED THAT THERE WAS A LEAD INTEGRITY ALERT WAS TRIGGERED, A POLARITY MODE SWITCH OCCURRED, VARYING IMPEDANCE AND HIGH IMPEDANCE, AND OVERSENSING ON THE VENTRICULAR LEAD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE 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. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) IMPLANTABLE PULSE GENERATOR