BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2813084 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16722
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    August 2, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 TO THE MANUFACTURER AND ANALYZED AND NO ANOMALIES WERE FOUND. THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED); THE INNER INSULATION AND INNER TUBING WERE KINKED BUCKLED. THE OUTER INSULATION HAD COSMETIC CUT. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. THERE WAS TISSUE ON THE HELIX; THE LEAD WAS STRETCHED AND HAD APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DAY AFTER THE IMPLANT PROCEDURE THE LEAD HAD HIGH THRESHOLD AND NO CAPTURE. THE LEAD WAS EXPLANTED AND REPLACED. 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. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R