BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2050995 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05468
    Event Type
    Injury
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED AND ALL CONDUCTORS WERE FRACTURED. THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED) ON THE PROXIMAL CONDUCTOR. THERE WAS A COSMETIC ENVIRONMENTAL STRESS CRACK, A BREACHED CUT, AND A COSMETIC DEPRESSION ON THE OUTER INSULATION AND ALL INSULATION WAS TORN. THE LEAD WAS FLEXED WITHIN 5CM OF THE ANCHORING SLEEVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR A RIGHT ATRIAL LEAD REVISION AND DURING THE PROCEDURE, IT WAS NOTED THAT THE LEAD WAS BROKEN, HAD HIGH IMPEDANCE, AND WAS NOT CAPTURE NOR SENSING. PART OF THE LEAD WAS EXPLANTED AND A REPLACEMENT LEAD WAS 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. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4076 IMPLANTABLE PACING LEAD| ADDRL1 IMPLANTABLE PULSE GENERATOR