BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3071827 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05258
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (B)(6) 2013; (B)(4) IMPLANTABLE TACHY LEAD (B)(6) 2013; (B)(4) IMPLANTABLE PACING LEAD (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY SEVEN DAYS AFTER IMPLANT, THERE WAS NO SENSING AND LOW LEAD IMPEDANCE THROUGH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ON THE RIGHT ATRIAL (RA) LEAD, THE RIGHT VENTRICULAR (RV) LEAD, AND THE LEFT VENTRICULAR (LV) LEAD. ALL MEASUREMENTS APPEARED TO BE NORMAL FOR ALL THREE LEADS THROUGH THE ANALYZER. ALSO, THE ICD BATTERY VOLTAGE DIPPED TO BELOW END OF LIFE (EOL) LEVELS FOR THREE CONSECUTIVE DAILY MEASUREMENTS WITHOUT TRIGGERING EOL OPERATION. THE ICD WAS EXPLANTED AND REPLACED. ALL THREE LEADS 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
    172633 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Hospitalization| R