BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2791182 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14504
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 THE PATIENT WAS IN INTENSIVE CARE AND BEING MONITORED WHEN THE PHYSICIAN QUESTIONED IF THE ATRIAL LEAD WAS SENSING INAPPROPRIATELY BASED ON THE CAPTURED ELECTROGRAM (ECG) EVENT. IT IS UNKNOWN WHETHER THE PATIENT'S IN INTENSIVE CARE EXPERIENCE WAS DEVICE RELATED AS WELL AS IF THERE WAS ANY MEDICAL INTERVENTION AS A RESULT OF THE REPORT THAT THE ATRIAL LEAD WAS SENSING INAPPROPRIATELY. THE ATRIAL LEAD REMAINS 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. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other 5076 IMPLANTABLE PACING LEAD| ADDR01 IMPLANTABLE PULSE GENERATOR