BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3742807 · Received April 11, 2014

    Report

    Report Number
    2649622-2014-03705
    Event Type
    Injury
    Date Received
    April 11, 2014
    Report Date
    February 12, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 PRODUCT: 4076 IMPLANTABLE PACING LEAD, (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN FOR A DEVICE INTERROGATION. UPON INTERROGATION, NO P-WAVES WERE SENSED ON THE ATRIAL LEAD. THE ATRIAL SENSITIVITY WAS ADJUSTED AND THERE WERE STILL NO P WAVES. THE PACING WAS ADJUSTED AND THERE WAS NO CAPTURE AT MAXIMUM OUTPUT. THE PATIENT WAS HOSPITALIZED DUE TO CONGESTIVE HEART FAILURE SYMPTOMS UNRELATED TO THE LEAD PERFORMANCE. THE LEAD REMAINS IN USE AND THE LEAD STATUS WILL BE INVESTIGATED DURING THE HOSPITALIZATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222291 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4592-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention ADDR01 IMPLANTABLE PULSE GENERATOR