BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3992759 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09694
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 PRODUCT: D224TRK CRT-D, IMPLANTED: (B)(6) 2009; 419688 LEAD, IMPLANTED: (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AND HIGH IMPEDANCES, AND WAS POSSIBLY FRACTURED. WHEN THE LEAD WAS PROGRAMMED AT OR ABOVE THRESHOLD, DIAPHRAGMATIC STIMULATION WAS OBSERVED. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FREQUENT ATRIAL UNDERSENSING, RESULTING IN MULTIPLE MODE SWITCHES AND ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION RECORDING. THE PHYSICIAN WAS UNABLE TO REPLACE THE LV LEAD DUE TO LACK OF VENOUS ACCESS, SO THE DEVICE WAS REPROGRAMMED TO VVIR MODE. ATRIAL SENSITIVITY WAS ALSO REPROGRAMMED, AND PR LOGIC WAS DISABLED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470460 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| R 7121 LEAD