BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2791162 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14503
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 6, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 ANALYZED. NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS FOUND ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED) AND THE OUTER INSULATION WAS BREACHED CUT. BLOOD WAS FOUND IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD APPEARED TO HAVE BEEN DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE RIGHT VENTRICULAR [RV] LEAD WAS REPOSITIONED MULTIPLE TIMES BUT HAD POOR SENSING AND HIGH THRESHOLD MEASUREMENTS. THE PHYSICIAN REMOVED THE LEAD STATING THAT THERE WERE "POSSIBLE PROBLEMS." A DIFFERENT RV 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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other