BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1050033 · Received May 8, 2008

    Report

    Report Number
    2649622-2008-02595
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    August 15, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    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: NO ANOMALIES FOUND; FULL LEAD RETURNED AND ANALYZED. OTHER: IT WAS REPORTED THE RV LEAD EXPERIENCED A "SUDDEN DROP" IN IMPEDANCE, HIGH THRESHOLDS, AND NO CAPTURE, FOLLOWING THE PATIENT'S AV NODE ABLATION PROCEDURE. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ELECTRICAL TESTS PERFORMED; MECHANICAL TESTS PERFORMED. VISUAL EXAMINATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED; DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CAPTURE, FAILURE TO, IMPEDANCE, LOW, HIGH THRESHOLD.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RV LEAD EXPERIENCED A "SUDDEN DROP" IN IMPEDANCE, HIGH THRESHOLDS, AND NO CAPTURE, FOLLOWING THE PATIENT'S AV NODE ABLATION PROCEDURE. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 71 YR Required Intervention P1501DR IMPLANTABLE PULSE GENERATOR| 4076 IMPLANTABLE PACING LEAD