BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2200665 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11044
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    June 8, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 FIBROSIS BETWEEN THE ATRIAL LEAD AND VENTRICULAR LEAD CAUSED THE ATRIAL LEAD TO DISLODGE AND TO TWIST WHEN THE RIGHT VENTRICULAR LEAD WAS REMOVED. THE ATRIAL LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD| D154ATG IMPLANTABLE PACEMAKER/CARDIO/DEFIB