BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREEPI

    MDR report key: 3991484 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08096
    Event Type
    Injury
    Date Received
    August 8, 2014
    Report Date
    May 6, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. PRODUCT ID (B)(4) LEAD IMPLANTED: 2013 (B)(6); PRODUCT ID A2DR01 IPG IMPLANTED: 2013 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS HIGH THRESHOLDS ON THE RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) LEADS. THE DEVICE WAS REPROGRAMMED AND THE LEADS 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
    471095 CAPSUREEPI ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4968-60

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention 4968-60 LEAD