BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1924163 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13439
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE ATRIAL AND VENTRICULAR LEAD WARNINGS. THE ATRIAL LEAD WARNING WAS FROM A YEAR AGO FOR HIGH IMPEDANCE, BUT HAS BEEN STABLE FOR THE LAST 6 MONTHS. THE VENTRICULAR WARNING COINCIDED WITH SHOULDER SURGERY NEAR THE IMPLANT SITE. THE LEADS ARE STILL IN USE. 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. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other (B)(4) IMPLANTABLE PULSE GENERATOR