BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2812721 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15712
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 4, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 DURING A SCHEDULED DEVICE CHANGE-OUT, THE ATRIAL LEAD WAS TESTED THROUGH THE ANALYZER AND HAD NORMAL SENSING AND THRESHOLD MEASUREMENTS; THE LEAD WAS THEN CONNECTED TO THE NEW DEVICE. APPROXIMATELY FIVE HOURS AFTER THE PROCEDURE, THE ATRIAL LEAD SENSING HAD DROPPED SIGNIFICANTLY AND THE THRESHOLD HAD RISEN. THE PHYSICIAN DECIDED TO OPEN THE POCKET; THE ATRIAL LEAD WAS AGAIN TESTED THROUGH THE ANALYZER AND IT SHOWED SIMILAR NUMBERS TO THOSE SEEN THROUGH THE NEW DEVICE. THE ATRIAL LEAD WAS CAPPED AND REPLACED. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R D314DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD