BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3992980 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09543
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 21, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 : VEDR01 IPG, IMPLANTED (B)(6) 2009. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED THE VENTRICULAR CAPTURE MANAGEMENT (VCM) TREND SHOWED THE RIGHT VENTRICULAR LEAD MAXIMUM THRESHOLD HAD BEEN GREATER THAN OR EQUAL TO 2.5 VOLTS THROUGHOUT THE RECORD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD HIGH THRESHOLD AND DECREASED SENSING OF R WAVES. MANUAL THRESHOLD TESTING WAS PERFORMED AND NO UNDERSENSING WAS NOTED, SO THE LEAD WAS REPROGRAMMED TO THE UNIPOLAR CONFIGURATION AT AN OUTPUT WHERE CONSISTENT CAPTURE WAS MAINTAINED AND NO POCKET STIMULATION OCCURRED, AND THE SENSITIVITY WAS ADJUSTED TO ENSURE APPROPRIATE R WAVE SENSING. 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
    472377 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5054

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR Required Intervention 5554-45 LEAD