BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 3990534 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08614
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 PRODUCT: MODEL: 5068-58, LEAD; IMPLANT: (B)(6) 2000. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS RIGHT ATRIAL (RA) LEAD WAS EXHIBITING HIGH IMPEDANCE LEVELS, AND A POSSIBLE FRACTURE IS SUSPECTED. DURING A DEVICE CHANGEOUT PROCEDURE A VISUAL INSPECTION WAS DONE AND THE HIGH IMPEDANCE LEVELS WERE NOT ABLE TO BE REPRODUCED WITH EXTENSIVE TESTING, LEAD MANIPULATION, AND ANALYZER TESTING. THE LEAD REMAINS IN USE AND WILL CONTINUE TO BE MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471991 CAPSUREFIX DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6940-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR E2DR01AA, IPG