BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3993484 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09293
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. PRODUCT EVENT SUMMARY: THE FULL LEAD IN SEGMENTS WAS RETURNED AND ANALYZED; ANALYSIS REVEALED A FLEX FRACTURE OF THE DISTAL CONDUCTOR. CONCOMITANT MEDICAL PRODUCTS: D274DRG ICD, IMPLANTED (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD WAS POSSIBLY FRACTURED. HIGH IMPEDANCE WAS NOTED AND OVERSENSING WAS OBSERVED ON THE ELECTROGRAM (EGM). IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS OVERSENSING AND NOISE WAS PRESENT ON THE NON-SUSTAINED VENTRICULAR TACHYCARDIA (VT-NS) EPISODES. THE LEADS WERE EXPLANTED 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
    466711 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Hospitalization| R 6947-65 LEAD