BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2812429 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15691
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 4, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 ANALYSIS FOUND THAT THE DISTAL CONDUCTOR WAS DISTORTED. THE PROXIMAL CONDUCTOR WAS DISTORTED. THE DISTAL AND PROXIMAL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE INNER INSULATION AND INNER TUBING WERE KINKED BUCKLED. THE OUTER INSULATION WAS BREACHED CUT. THE HELIX/LOBE WAS DISTORTED/BENT AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. THE GUIDETOOTH WAS DAMAGED AND THE LEAD WAS STRETCHED. VISUAL ANALYSIS NOTED THAT THE LEAD WAS DAMAGED AT IMPLANT AND THAT THE HELIX WOULD NOT EXTEND OR RETRACT DUE TO THE DISTORTION IN THE DISTAL CONDUCTOR WITHIN THE CONNECTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN HAD DIFFICULTY MOVING THE LEAD DUE TO THE PATIENT'S ANATOMY. AFTER THE LEAD WAS POSITIONED, IT DISLODGED MULTIPLE TIMES. EVENTUALLY THE HELIX OF THE LEAD WOULD NO LONGER RETRACT. THE LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other