BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4161817 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11400
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 PRODUCTS: 37702 PAIN STIM IPG (B)(6) 2011; IW1414C90XH STENT GRAFT (B)(6) 2010; AF2814C140XH STENT GRAFT (B)(6) 2010; 3776-60 PAIN STIM LEAD (B)(6) 2009; 3776-60 PAIN STIM LEAD (B)(6) 2009; 6948-65 LEAD (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. THE EPISODE WAS NOTED TO HAVE STARTED IN THE VT MONITOR ZONE THEN INCREASED IN RATE TO THE VF ZONE. THE ATRIAL LEAD ALSO APPEARED TO BE UNDERSENSING. THE DETECTION RATE WAS INCREASED AND THE DEVICE REMAINS IN USE. THE LEAD ALSO REMAINS 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
    639646 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Life Threatening| R D314DRG ICD