BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1992480 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02871
    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
    PA, 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 NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANT THE LEAD HAD NO CAPTURE, A RISE IN THRESHOLDS LEVELS AND THE SENSING AMPLITUDE HAD GONE DOWN. A LEAD REVISION WAS DONE AND DURING THE REVISION THE LEAD PERFORATED THE RIGHT VENTRICLE. THE LEAD WAS REMOVED AND DURING EXPLANT A SMALL NICK WAS MADE ON THE PROXIMAL PORTION OF THE LEAD INSULATION. A NEW LEAD WAS IMPLANTED. NO FURTHER 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 84 YR Hospitalization| L| R 5076 IMPLANTABLE PACING LEAD| (B)(4) COMPETITOR IMPLANTABLE PULSE GENERATOR