BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3861779 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01749
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    January 1, 2013
    Report Date
    April 9, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PACEMAKER IMPLANTED WITH COMPETITOR LEADS IN (B)(6) 2012. SIX MONTHS LATER, THE PATIENT BEGAN EXPERIENCING DIAPHRAGMATIC STIMULATION. IT WAS FURTHER REPORTED THAT IN 2014 THE PATIENT'S VENTRICLE LEAD WAS REPLACED WITH A MEDTRONIC LEAD, HOWEVER, THE PATIENT STILL EXPERIENCED DIAPHRAGMATIC STIMULATION. FINALLY, THE PHYSICIAN CHOSE TO REMOVE AND REPLACE THE PACEMAKER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341752 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| L| R SEDRL1 IPG