BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3153311 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05930
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 6, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 WAS RETURNED, ANALYZED, AND NO ANOMALIES FOUND, THE PROXIMAL CONDUCTOR OF THE LEAD WAS DISTORTED DUE TO KINKING/BUCKLING AND PULLED/STRETCHED/OVERSTRESS, THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED, THE DISTAL LV (LEFT VENTRICULAR) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD AND THE HELIX OF THE LEAD WAS BENT AND DISTORTED DUE TO PULL/STRETCH/OVERSTRESS. THE OUTER INSULATION OF THE LEAD WAS BREACHED DUE TO A CUT. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE AND STRETCHING. THE ANALYST COMMENTED THAT THE LEAD WAS RETURNED WITH THE HELIX DISTORTED/BENT//PULLED/STRETCHED/OVERSTRESS. THEREFORE HELIX LENGTH CANNOT BE TESTED. CONCOMITANT MEDICAL PRODUCTS: D334TRM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR: (B)(6) 2012. 4194 IMPLANTABLE PACING LEAD: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD WAS FOUND TO BE DISLODGED DURING AN ELECTROPHYSIOLOGY STUDY. THE PHYSICIAN DECIDED TO REPOSITION THE LEAD BUT IT CAME OUT. A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255974 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407645

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| R 6947M IMPLANTABLE TACHY LEAD