BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2953491 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01155
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    December 17, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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, ANALYZED, AND THE DISTAL CONDUCTOR WAS FLEXED AND FRACTURED. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED FROM FIRST RIB/CLAVICLE, THERE WAS BLOOD IN THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS BLOOD IN THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS BLOOD IN THE DISTAL ELECTRODE, THE OUTER INSULATION WAS BREACHED CUT, THE OUTER INSULATION WAS BREACHED DUE TO FIRST RIB/CLAVICLE, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, AND THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD HIGH IMPEDANCE. 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
    56473 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)