BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 5420897 · Received February 9, 2016

    Report

    Report Number
    2649622-2016-00444
    Event Type
    Injury
    Date Received
    February 9, 2016
    Date of Event
    December 11, 2015
    Report Date
    December 11, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY:THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. THE ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED LOWER RANGE. RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE TREND NOT AVAILABLE, HOWEVER AT INTERROGATION RV PACING IMPEDANCE MEASURED 192 OHMS. A 5061886 SHORT CIRCUIT COUNTS SINCE (B)(6) 2015. THE ANALYSIS OF THE DEVICE MEMORY INDICATED PACING CAPTURE THRESHOLD IN THE RV (RIGHT VENTRICLE) WAS ELEVATED. ON (B)(6) 2014, RV CAPTURE THRESHOLD HAS RISEN TO GREATER THAN 2.5 V AND IS CONSISTENTLY ABOVE 2.5 V.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD A LEAD WARNING FOR LOW IMPEDANCE. THE LEAD ALSO HAD UNDERSENSING AND WHEN TESTED THE LEAD HAD OVERSENSING AND NOISE WHEN THE PATIENT RAISED THEIR ARM. ADDITIONALLY, AN INSULATION BREACH WAS DETECTED. THE LEAD WAS REPROGRAMMED AND REMAINS IN USE. THE PATIENT WILL BE MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77748 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5054-58

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention