BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z

    MDR report key: 3862603 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06799
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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: PRODUCT ID: KDR901 IPG, IMPLANTED: (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD WAS UNDERSENSING ATRIAL FIBRILLATION (AF) WAVES THROUGH THE ANALYZER AT 0.25 MV SENSITIVITY. THE PATIENT IS IN CHRONIC AF. THE ATRIAL LEAD WAS CAPPED AND WAS NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339169 CAPSURE Z ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 553453

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Hospitalization| R 5034-58 LEAD