BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREEPI

    MDR report key: 4162554 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12695
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 4, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE BIPOLAR EPICARDIAL LEAD WAS ATTEMPTED AND NOT USED DUE TO HIGH THRESHOLDS AND UNDERSENSING AFTER SEVERAL REPOSITIONINGS. A SECOND BIPOLAR EPICARDIAL LEAD WAS ATTEMPTED AND NOT USED DUE TO HIGH THRESHOLDS AFTER SEVERAL REPOSITIONINGS. NO LEAD WAS IMPLANTED THAT DAY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643606 CAPSUREEPI ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4968-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR