BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2790703 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14763
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    July 26, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 ATRIAL LEAD HAD NO ATRIAL SENSING DUE TO SILENT ATRIUM OR EXTREMELY SMALL P-WAVES DURING AF (ATRIAL FIBRILLATION). IT WAS ALSO NOTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY FOR AN EPISODE OF AF WITH RVR (RAPID VENTRICULAR RESPONSE). THE DISCRIMINATOR WAS REPROGRAMED FOR THE ATRIAL SENSING ISSUE AND THE 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 58 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947M IMPLANTABLE TACHY LEAD