BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE

    MDR report key: 3152389 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06823
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    May 30, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 PRODUCTS: 4003M IMPLANTABLE PACING LEAD IMPLANTED: 1995 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THERE WAS A LEAD WARNING FOR LOW IMPEDANCE ON THE ATRIAL LEAD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A LEAD WARNING FOR LOW IMPEDANCE ON THE ATRIAL LEAD. THE DEVICE WAS REPROGRAMMED AND THE LEAD REMAINS 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
    253009 CAPSURE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4503M53

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)