BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3864632 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07405
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. CONCOMITANT MEDICAL PRODUCTS: A 5092 IMPLANTABLE PACING LEAD: (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A CARDIOVERSION PROCEDURE, THERE WAS A TEMPORARY LOSS OF CAPTURE IN BOTH ATRIAL AND VENTRICLE PACING. THE PATIENT WAS ASYSTOLIC IMMEDIATELY FOLLOWING THE CARDIOVERSION. REPROGRAMMING WAS DONE TO INCREASE RIGHT VENTRICLE OUTPUT. BOTH OF 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
    339209 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Life Threatening| R ADDR01 IMPLANTABLE PULSE GENERATOR