BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2811036 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16333
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 13, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    THE INCORRECT SUSPECT MEDICAL DEVICE MODEL 5076/ SERIAL (B)(4) WAS INADVERTENTLY REPORTED FOR THIS COMPLAINT UNDER MANUFACTURING REPORT NUMBER 2649622-2012-16333 AND AS A RESULT THIS REPORT IS BEING REDACTED. THE AVAILABLE INFORMATION REASONABLY SUGGESTS THAT A MEDTRONIC PRODUCT WAS NEITHER A CAUSE NOR A CONTRIBUTING FACTOR IN A DEATH OR SERIOUS INJURY AND THE AVAILABLE INFORMATION REASONABLY SUGGESTS THAT THE DEVICE WAS ABLE TO PERFORM ITS ESSENTIAL FUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE AND RIGHT VENTRICULAR AND RIGHT ATRIAL LEADS WERE IMPLANTED AFTER THE USE-BEFORE DATE. THE LEAD REMAINS IN USE. THE DEVICE WAS REMOVED AND REPLACED ON THE SAME DAY IT WAS IMPLANTED. NO COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE LEADS AND DEVICE WERE NOT IMPLANTED AFTER THE USE-BEFORE DATE AND THE DEVICE WAS REMOVED AFTER EIGHT YEARS DUE TO ELECTIVE REPLACEMENT INDICATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE AND RIGHT VENTRICULAR AND RIGHT ATRIAL LEADS WERE IMPLANTED AFTER THE USE-BEFORE DATE. THE LEAD REMAINS IN USE. THE DEVICE WAS REMOVED AND REPLACED ON THE SAME DAY IT WAS IMPLANTED. NO COMPLICATIONS WERE NOTED 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

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Other