BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 4161777 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11418
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 29, 2014
    Report Date
    July 29, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 MEDICAL PRODUCTS: 5076-58 LEAD, IMPLANTED (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A HIGH HEART RATE. THE RIGHT ATRIAL (RA) LEAD HAD INTERMITTENT P-WAVE SENSING. CLEAR P-WAVES WITH INTERMITTENT ATRIAL SENSE MARKERS WERE NOTED. THE ATRIAL ELECTROGRAM WAS VERY NOISY WITH ALMOST A SOLID BLACK SIGNAL. REPROGRAMMING WAS PERFORMED, BUT THE INTERMITTENT UNDERSENSING WAS STILL OBSERVED. 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
    639226 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4592-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00091 YR Required Intervention SEDR01 IPG