BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 1990236 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-01896
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    November 25, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S2
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 AND ANALYZED. ANALYSIS REVEALED THAT THE DISTAL CONDUCTOR WAS DISTORTED DUE TO THE CONNECTOR PIN BEING TURNED AN EXCESSIVE NUMBER OF TIMES WHEN THE HELIX WAS ALREADY RETRACTED DURING THE PROCEDURE. THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND THERE WAS A NON-ELECTRICAL MISCELLANEOUS FINDING ON THE TIP ELECTRODE. VISUAL ANALYSIS INDICATED DAMAGE AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, AFTER A FEW POSITIONING ATTEMPTS, IT WAS NOT POSSIBLE TO EXTEND THE HELIX ANY MORE. THE LEAD WAS NOT USED, AND ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5568 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other