BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 8623100 · Received May 20, 2019

    Report

    Report Number
    2649622-2019-08483
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    April 21, 2019
    Report Date
    May 20, 2019
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00681490124812
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: IEXCH182485, STENT GRAFT, IMPLANTED: (B)(6) 2010; ILXCH1616115, STENT GRAFT, IMPLANTED: (B)(6) 2010; AF3416C155XH, STENT GRAFT, IMPLANTED: (B)(6) 2010; IEXCH182485, STENT GRAFT, IMPLANTED: (B)(6) 2010; 1258T LEAD, IMPLANTED: (B)(6) 2015; D314TRG CRT-D, IMPLANTED: (B)(6) 2015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. THE LEAD 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
    418068 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52 00681490124812

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR 694765 LEAD