BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2203546 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-12352
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    June 1, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FS
    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) ANALYSIS OF THE FULL LEAD FOUND THE OUTER INSULATION KINKED/BUCKLED. FURTHERMORE, IT WAS NOTED THAT THE DISTAL CONDUCTOR CONNECTOR PIN WAS BENT, ALL CONDUCTORS WERE STRETCHED, THE LEAD WAS STRETCHED, AND THE LEAD APPEARED DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT OF THE LEAD, THE PHYSICIAN TRIED TO PASS THE LEAD INTO THE INTRODUCER, BUT EXPERIENCED DIFFICULTIES. IT WAS NOTED THAT THERE WAS INSULATION DAMAGE OF THE LEAD. THE LEAD WAS NOT USED. 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. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other