BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1854663 · Received October 5, 2010

    Report

    Report Number
    2649622-2010-09132
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED. PRIMARY ANALYSIS FINDING: THE OUTER INSULATION WAS BREACHED CUT. BLOOD/BODY FLUID WAS PRESENT ON THE PROXIMAL CONDUCTOR AND IN/ON THE HELIX MECHANISM. VISUAL ANALYSIS NOTED THE PROXIMAL CONDUCTOR WAS DISTORTED, AND THERE WAS DAMAGE AT IMPLANT NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE PROXIMAL END OF THE RIGHT VENTRICULAR LEAD APPEARED TO HAVE BEEN DAMAGED BY FRICTION WHEN TRYING TO ADVANCE IT, IN THE SHEATH, INTO A DIFFICULT SUBCLAVIAN VEIN. THE LEAD WAS NOT USED AND ANOTHER OF THE SAME MODEL 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 NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention