BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2952670 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00649
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    December 4, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. ANALYSIS REVEALED THE DISTAL CONDUCTOR WAS FRACTURE/FLEXED. IT WAS NOTED THAT THE OUTER INSULATION WAS CUT. OUTER INSULATION COSMETIC FINDINGS INCLUDED; MELTED, ENVIRONMENTAL STRESS CRACKING (ESC), WHITE SUBSTANCE, AND DEPRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FLUOROSCOPY WAS DONE AND THE ATRIAL LEAD WAS DISLODGED TO THE TRICUSPID VALVE AREA. THE ATRIAL LEAD HAS A HISTORY OF HIGH CHRONIC THRESHOLDS. THE LEAD WAS 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
    56233 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD