BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3993604 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02303
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 26, 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 U.S. WHERE A SIMILAR 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 DURING AN IMPLANT PROCEDURE, THE PHYSICIAN COMPLAINED THAT THERE WAS NO COLOR DIFFERENCE BETWEEN THE DIFFERENT LEAD LENGTHS. THEY PHYSICIAN CONNECTED THE LEADS WRONG IN THE ATRIUM AND VENTRICLE PORTS IN THE DEVICE AND HAD TO RE-OPEN THE PATIENT AND CHANGE THE LEAD CONNECTIONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472662 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 5076-58 LEAD