BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1990920 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02178
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED AND HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE OUTER INSULATION HAD A BREACHED CUT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POST IMPLANT CHECK, THE RIGHT ATRIAL LEAD HAD LOW IMPEDANCE, WAS UNDERSENSING, AND THE POLARITY HAD CHANGED. THE PHYSICIAN RE-OPENED THE PATIENT AND NOTICED THAT THE LEAD HAD AN INSULATION BREACH WHICH THE PHYSICIAN THOUGHT COULD HAVE HAPPENED DURING SHEATH REMOVAL. THE LEAD WAS EXPLANTED AND ANOTHER 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. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other