BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3862424 · Received June 10, 2014

    Report

    Report Number
    3008973940-2014-00205
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 6, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 NO R-WAVE MEASUREMENTS WERE OBSERVED FROM THE RIGHT VENTRICULAR (RV) LEAD NOR P-WAVE MEASUREMENTS FROM THE RIGHT ATRIAL (RA) LEAD. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT PACING AND FAILED A THRESHOLD TEST. DURING A REVISION IN WHICH THE CONNECTION WAS TO BE ASSESSED, THE IPG WAS EXPLANTED AND REPLACED. THE RA AND RV LEADS REMAIN 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
    338541 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 407658

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR SVDD03 IPG