BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3993999 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09021
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 20, 2014
    Report Date
    December 9, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND NO ANOMALIES WERE FOUND. THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. THE ANALYST NOTED THE RETURNED LEAD WAS THOROUGHLY ANALYZED (INCLUDING DESTRUCTIVE ANALYSIS) IN AN ATTEMPT TO FIND AN EXPLANATION FOR THE FAR FIELD OVERSENSING DESCRIBED IN THE EVENT. THERE WERE NO ANOMALIES OBSERVED. AN IN-VIVO INSULATION BREACH OR CONDUCTOR FRACTURE WAS NOT OBSERVED DURING ANALYSIS. ALL VISUAL ANALYSIS WAS WITHIN SPECIFIED PARAMETERS. THE FULL LEAD WAS NOT RETURNED. BLOOD INGRESS WAS OBSERVED THROUGHOUT THE DISTAL CONDUCTOR. THE LEAD WAS RETURNED IN SEVERAL PIECES WITH EXPLANT DAMAGE THEREFORE THE SOURCE OF THE BLOOD INGRESS COULD NOT BE DETERMINED DURING ANALYSIS. ALL OF THE OUTER INSULATION COULD NOT BE ACCOUNTED FOR.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: D224DRG ICD, IMPLANTED: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    DURING A REVISION PROCEDURE, THE LEAD WAS NOTED TO HAVE BLOOD INTRUSION WITHIN THE LUMEN. THE LEAD WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD FAR FIELD OVERSENSING ON THE RIGHT ATRIAL LEAD. PROGRAMMING WAS ATTEMPTED, BUT WAS NOT ABLE TO ALLEVIATE THE OVERSENSING. 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
    470981 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| R