BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3990888 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08440
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. EVENT PRODUCT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. CONCOMITANT MEDICAL PRODUCTS: A 5076-45 LEAD: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELT TIRED DUE TO THEIR RIGHT ATRIAL (RA) LEAD EXHIBITING UNDERSENSING AND NO CAPTURE. THE RA LEAD WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471087 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R P1501DR IPG