BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2864960 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17559
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    October 9, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 6945 IMPLANTABLE DEFIB LEAD (B)(6) 2001. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE MAY BE REACHING THE ELECTIVE REPLACEMENT INDICATOR [ERI] PREMATURELY. IT WAS ALSO REPORTED THAT THE ATRIAL LEAD IMPEDANCE WAS NOT MEASURED FOR APPROXIMATELY TWO WEEKS AND ATRIAL UNDERSENSING WAS SEEN ON THE PATIENT'S ELECTROGRAM. ATTEMPTS TO REPROGRAM THE DEVICE TO ADDRESS THE ATRIAL LEAD UNDERSENSING WERE UNSUCCESSFUL. THE DEVICE AND ATRIAL LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5068

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention (B)(4) IMPLANTABLE DEFIBRILLATOR