BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1792437 · Received August 11, 2010

    Report

    Report Number
    2649622-2010-07108
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    May 7, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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) NO ANOMALIES FOUND; BLOOD OBSERVED IN/ON THE HELIX MECHANISM; FULL LEAD ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING THE IMPLANT PROCEDURE, FOUR CONSECUTIVE IMPEDANCE READINGS WITH VALUES GREATER THAN 1400 WERE OBSERVED DESPITE POSITION. CONSEQUENTLY, THIS LEAD WAS WITHDRAWN AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS 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 Other