BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1875102 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11623
    Event Type
    Injury
    Date Received
    October 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS INTERMITTENT OUTPUT SEEN VIA HOLTER MONITOR, AS WELL AS INTERMITTENT HIGH IMPEDANCE, > 3000 OHMS. AT THE TIME OF LEAD REVISION, WHEN INSERTING A WRENCH INTO THE ATRIAL LEAD IN DEVICE HEADER, THERE WERE AIR BUBBLES AND FLUID NOTED BEING RELEASED AT THE GROMMET. THE LEAD WAS TESTED THROUGH AN ANALYZER, WITH GOOD SENSING AND CAPTURE. THE LEAD WAS LEFT IN USE AND THE PACEMAKER WAS REPLACED. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention 5076-52 IMPLANTABLE PACING LEAD| 5071 IMPLANTABLE PACING LEAD