BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3860883 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05269
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    February 25, 2014
    Report Date
    March 3, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    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 PRODUCT: 407658 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME IN FOR FOLLOWUP COMPLAINING OF SOME MOMENTARY DIZZY SPELLS AND THE ATRIAL LEAD WAS FOUND TO HAVE NON-CAPTURE, EVEN WHEN OUTPUT WAS INCREASED TO MAX. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342648 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R ADDR01 IMPLANTABLE PULSE GENERATOR (IPG)