BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4162236 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12853
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. PRODUCT EVENT SUMMARY:THE FULL LEAD WAS RETURNED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. HOWEVER, THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD. THE LEAD WAS RECEIVED WITH BLOOD ON THE HELIX. THE HELIX WAS CLEANED IN PREPARATION FOR HELIX EXTENSION/RETRACTION AND LENGTH TESTING. EXTENSION/RETRACTION AND LENGTH TESTING WERE PERFORMED AND ALL RESULTS, INCLUDING ELECTRICAL TESTING, WERE WITHIN SPECIFIED PARAMETERS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THERE WERE MULTIPLE ATTEMPTS TO PLACE THE LEAD. THE PHYSICIAN WAS WORRIED ABOUT TISSUE IN THE LEAD¿S HELIX AND REMOVED THE LEAD. THERE WAS NO TISSUE IN THE HELIX; HOWEVER, THE PHYSICIAN REQUESTED A NEW LEAD. THE NEW LEAD 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
    639535 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR