BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2953205 · Received February 9, 2013

    Report

    Report Number
    3008973940-2013-00013
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 30, 2012
    Report Date
    February 27, 2013
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - US FDA MDR - PRODUCT EVENT SUMMARY (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DISTAL END/ELECTRODES WERE COVERED IN BLOOD AND WITH BODY TISSUE/FIBROTIC GROWTH. ANALYSIS COMMENTS: THE LEAD WAS RETURNED WITH THE HELIX FULLY RETRACTED AND BLOOD AND TISSUE IN IT. HOWEVER, HELIX WAS ABLE TO BE EXTENTED AND RETRACTED WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT THE LEAD COULD NOT BE PLACED IN THE VENTRICLE. IT WAS ALSO REPORTED THAT WHEN THE PHYSICIAN REMOVED THE LEAD THERE WAS TISSUE ON THE HELIX. WHILE EXERCISING THE HELIX OUTSIDE OF THE BODY, HELIX EXTENSION "TOOK TIME BUT THEN IT CAME OUT IMMEDIATELY". THE LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55682 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1