BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3990026 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08854
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 1, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. CONCOMITANT MEDICAL PRODUCTS: D334DRG DEVICE, IMPLANTED (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S HEART RATE DROPPED WHEN HE WAS TURNED ON HIS LEFT SIDE. DURING A DEVICE CHECK THEY WERE ABLE TO REPRODUCE THE EVENT AND OBSERVED A LOSS OF SENSITIVITY ON THE RIGHT ATRIAL (RA) LEAD. THE PATIENT WENT FROM TRACKING AN ATRIAL RHYTHM AND PACING IN THE VENTRICLE AT 120 BPM WHILE SUPINE TO NO ATRIAL SENSING AND AN ACCELERATED JUNCTIONAL RHYTHM AROUND 75-80BPM WHILE ON HIS LEFT SIDE. IT WAS ALSO OBSERVED THAT HIS BLOOD PRESSURE WAS BETTER WITH THE LOWER RATE SO THE DEVICE WAS REPROGRAMMED TO VVI MODE AT A RATE OF 60 BPM. 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
    462506 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention 694965 LEAD