BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 4160887 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11723
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    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

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

    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. CONCOMITANT: PRODUCT ID 5054-58 LEAD IMPLANTED: 2001-(B)(6). (B)(4).

    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. ANALYSIS OF THE DEVICE MEMORY INDICATED ATRIAL OVERSENSING. APPARENT OVERSENSING IN ATRIAL HIGH RATE EPISODES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POLARITY SWITCH ON THE RIGHT ATRIAL (RA) LEAD DUE TO LOW IMPEDANCE. THE SENSITIVITY WAS CHANGED DUE TO POSSIBLE OVERSENSING. 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 ALSO REPORTED THE ATRIAL HIGH RATE (AHR) COUNTS (WHICH HAD BEEN ALLEGEDLY TRIGGERED BEEN BY MUSCLE POTENTIAL ALSO ALLEGEDLY TRIGGERED BY OVERSENSING) WERE SO HIGH THAT THE DEVICE WAS REPROGRAMMED FROM UNIPOLAR TO BIPOLAR MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642558 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5554-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention ADDRL1 IPG