BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2131113 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10394
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 5, 2011
    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
    CA
    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. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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): ALL CONDUCTORS DISTORTED, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD APPEARED DAMAGE AT IMPLANT; FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING IMPLANT ATTEMPT THAT THERE WERE DIFFICULTIES INTRODUCING THE LEAD INTO THE VEIN TO ACCESS THE ATRIUM. IT WAS ALSO REPORTED THAT WHEN THE LEAD WAS RETRIEVED TO OBTAIN A FURTHER ACCESS, THE DISTAL PART OF THE LEAD WAS CURVED WITHOUT A STYLET IN THE LEAD. THE LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING IMPLANT ATTEMPT THAT THERE WERE DIFFICULTIES INTRODUCING THE LEAD INTO THE VEIN TO ACCESS THE ATRIUM. IT WAS ALSO REPORTED THAT WHEN THE LEAD WAS RETRIEVED TO OBTAIN A FURTHER ACCESS, THE DISTAL PART OF THE LEAD WAS CURVED WITHOUT A STYLET IN THE LEAD. THE LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE 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