BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREEPI

    MDR report key: 4832986 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-07318
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    March 12, 2015
    Report Date
    March 12, 2015
    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
    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 THE PATIENT EXPERIENCED SINUS BRADYCARDIA WITH A HEART RATE IN THE MID-30S (BEATS PER MINUTE) DUE TO THE EPICARDIAL LEAD NOT CAPTURING DUE TO DISLODGEMENT. THE LEAD ALSO HAD HIGH THRESHOLD AND LOW PACING IMPEDANCE; A POLARITY SWITCH OCCURRED, AS WELL AS A LEAD INTEGRITY ALERT. THE LEAD WAS REPOSITIONED AND 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
    375443 CAPSUREEPI ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4968-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Hospitalization| R ADSR01 IPG