BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3153255 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05898
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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: 5076 IMPLANTABLE PACING LEAD: (B)(6) 2013. ADDR01 IMPLANTABLE PULSE GENERATOR: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD DIAPHRAGMATIC STIMULATION WHEN PACED IN THE RIGHT VENTRICLE. THE RIGHT VENTRICULAR LEAD WAS NOTED TO HAVE HIGH THRESHOLD. THE LEAD WAS REPOSITIONED AND 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
    256071 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Hospitalization| R