BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 7802479 · Received August 21, 2018

    Report

    Report Number
    2649622-2018-13690
    Event Type
    Malfunction
    Date Received
    August 21, 2018
    Date of Event
    August 1, 2018
    Report Date
    February 27, 2019
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00643169633766
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: B890941 TRANSCATHTER VALVE, IMPLANTED: (B)(6) 2018. NON-HEALTHCARE PROFESSIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL PORTION OF THE LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. VISUAL ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT A RED ALERT WAS TRIGGERED FOR HIGH THRESHOLDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A STEADY INCREASE IN THRESHOLDS UNTIL THE VALUES WERE HIGH FOR NINE CONSECUTIVE DAYS. LOSS OF CAPTURE OF THE RV LEAD WAS SUSPECTED. 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
    644498 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58 00643169633766

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR