BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3861238 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07316
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD DISLODGED, THERE WAS INTERMITTENT CAPTURE, UNDERSENSING AND LOW RATES. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. IT WAS NOTED THAT THE LEAD HAD BEEN PLACED POST A TRANS AORTIC VALVE REPLACEMENT (TAVR) AND IT APPEARED THE SWAN CATHETER KNOCKED THE RV LEAD OUT FROM ITS POSITION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339665 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407658

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R SESR01 IPG