BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREEPI

    MDR report key: 3991566 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08038
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    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: ADDRL1 IPG, IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BECAME WEAK DURING A TREADMILL TEST PERFORMED A FEW DAYS EARLIER. INTERMITTENT LOSS OF CAPTURE WAS NOTED IN THE VENTRICLE. REPROGRAMMING WAS PERFORMED AND THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470597 CAPSUREEPI ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4968-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR Required Intervention 4968-60 LEAD