BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3051563 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04856
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 19, 2013
    Report Date
    April 30, 2020
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. CONCOMITANT PRODUCTS: 4298 IMPLANTABLE PACING LEAD 2013 (B)(6); (B)(4) IMPLANTABLE TACHY LEAD 2013 (B)(6); (B)(4) BI-VENTRICULAR DEFIBRILLATOR 2013 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SYSTEM UPGRADE PROCEDURE THE VENOUS ACCESS WAS REPORTED TO BE "TIGHT" AND THE CHRONIC RIGHT ATRIAL (RA) LEAD WAS OBSERVED TO HAVE MOVED. ONE DAY POST PROCEDURE, THERE WAS NO ATRIAL CAPTURE AND UNDERSENSING NOTED IN THE LEAD AND IT WAS CONFIRMED TO HAVE DISLODGED. THE LEAD WAS CAPPED AND REPLACED WITH A NEW LEAD. THE PATIENT WAS REPORTED TO BE ENROLLED IN THE ATTAIN PERFORMA CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152935 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407645

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R