BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1924508 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13592
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    September 22, 2010
    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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE LEAD IMPLANT PROCEDURE, THE TEST RESULTS USING THE PACING SYSTEM ANALYZER SHOWED THAT THERE WAS NO CAPTURE, HIGH IMPEDANCE AND NO SENSING. THE LEAD WAS REPOSITIONED BUT THAT DID NOT RESOLVE THE PROBLEMS ASSOCIATED WITH THE LEAD. THE LEAD WAS NOT USED, AND ANOTHER LEAD WAS USED WITH NORMAL READINGS. 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 Other