BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3993415 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09307
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 21, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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: D314TRG ICD, IMPLANTED: (B)(6) 2014; 6947 LEAD, IMPLANTED (B)(6) 2003. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED ANTI-TACHYCARDIA PACING (ATP) AND FOUR SHOCKS. THE ATP AND THREE SHOCKS FAILED TO CONVERT AN EPISODE IN THE VENTRICULAR TACHYCARDIA (VT) ZONE. ALSO, SOME ATRIAL UNDERSENSING WAS NOTED WHILE PATIENT IS IN FAST VT AT THE END OF THE EPISODE. THE DEVICE AND LEAD ARE STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469311 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR 429688 LEAD