BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2790716 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15055
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    April 1, 2012
    Report Date
    September 20, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS RISING. THE SAVE TO DISK REVEALED THAT THERE WAS A STEADY V (VENTRICULAR) LEAD IMPEDANCE INCREASE FROM APPROXIMATELY 400-500 OHMS IN (B)(6) 2012 UP TO APPROXIMATELY 1300 OHMS IN (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTEDTHAT THE RIGHT VENTRICULAR LEAD HAD HIGH THRESHOLDS AND IMPEDANCE. THE VENTRICULAR OUTPUTS WERE REPROGRAMMED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT A ROUTINE CHECK THE RIGHT VENTRICULAR LEAD'S IMPEDANCE HAD INCREASED. IT WAS NOTED THAT THE LEAD'S TREND SHOWS A GRADUAL INCREASE IN LEAD IMPEDANCE SINCE (B)(6) OF THIS YEAR. THE LEAD WAS REPROGRAMMED TO UNIPOLAR PACING CONFIGURATION AND 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
    1 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention (B)(4) IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD