BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2812513 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16197
    Event Type
    Malfunction
    Date Received
    October 31, 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
    HEALTH PROFESSIONAL

    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 WAS A LEAD WARNING ON THE VENTRICULAR LEAD NOTING THAT THE DIAGNOSTICS FOR THE LEAD BEING OUT OF RANGE WAS NOT FULLY REPRESENTED BY THE DATA MEASUREMENTS. IT WAS ALSO REPORTED THAT THE VENTRICULAR LEAD HAD HIGH IMPEDANCE AND OVERSENSING WHICH WAS ALSO NOTED AT THE LAST PROGRAMMER CHECK. IT WAS ALSO REPORTED THAT THERE WAS DUAL ELECTROGRAMS FOUND ON THE REMOTE PACEMAKER TRANSMISSION. THE VENTRICULAR LEAD AND THE DEVICE REMAIN IN USE. 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. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other 5076 IMPLANTABLE PACING LEAD