BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3864829 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07483
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 17, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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. CONCOMITANT MEDICAL PRODUCTS: A 419478 LEAD, IMPLANTED: (B)(6) 2008. A 694758 LEAD, IMPLANTED: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD INSULATION WAS DAMAGED DURING GENERATOR CHANGE. THE LEAD WAS SUTURED WITH MEDICAL ADHESIVE AND REMAINS IN SERVICE. ADDITIONALLY, THE ATRIAL LEAD INSULATION AND ANODE CONDUCTOR WERE DAMAGED DURING GENERATOR CHANGE. THE LEAD EXHIBITED HIGH IMPEDANCE AND NO CAPTURE. THE ATRIAL LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD INSULATION WAS DAMAGED DURING GENERATOR CHANGE. THE LEAD WAS SUTURED WITH MEDICAL ADHESIVE AND REMAINS IN SERVICE. ADDITIONALLY THE ATRIAL LEAD INSULATION AND ANODE CONDUCTOR WERE DAMAGED DURING GENERATOR CHANGE. THE LEAD EXHIBITED HIGH IMPEDANCE AND NO CAPTURE. THE ATRIAL LEAD WAS CAPPED AND REPLACED. AN ATRIAL LEAD WAS ATTEMPTED BUT NOT USED DURING THE IMPLANT PROCEDURE DUE TO SHORT LENGTH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337575 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Hospitalization| R C154DWK ICD