BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3990398 · Received August 7, 2014

    Report

    Report Number
    3008973940-2014-00281
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    February 4, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT: 5076-52 LEAD 2014-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF THE RIGHT VENTRICULAR LEAD (RV), THE LEAD HAD INCREASED THRESHOLD AND DISLODGEMENT WAS SUSPECTED. THE NEXT DAY THE LEAD WAS REPOSITIONED AND REMAINS IN USE. THE PATIENT IS ENROLLED IN THE (B)(6) STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464852 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R A3DR01 IPG