BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2964737 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02169
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 4092 IMPLANTABLE PACING LEAD - (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED A RISE IN THRESHOLDS, AND IT WAS NOT POSSIBLE TO VERIFY ATRIAL CAPTURE VIA THE ELECTROGRAM (EGM). FOLLOW UP IS IN PROCESS FOR ADDITIONAL INFORMATION. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED A RISE IN THRESHOLDS, AND IT WAS NOT POSSIBLE TO VERIFY ATRIAL CAPTURE VIA THE ELECTROGRAM (EGM). FOLLOW UP IS IN PROCESS FOR ADDITIONAL INFORMATION. IT WAS FURTHER REPORTED THAT THE LEAD WAS REPROGRAMMED AND REMAINS 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
    68183 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407645

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Required Intervention (B)(4) IMPLANTABLE PACEMAKER