BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4831476 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05491
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 23, 2015
    Report Date
    April 23, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR 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

    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 THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE AND OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER).

    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 PACING FAILURE WAS NOTED. A DEVICE CHECK WAS CONDUCTED WHICH REVEALED HIGH LEAD IMPEDANCE AND A POLARITY SWITCH. A LARGE NUMBER OF VENTRICULAR HIGH RATE EPISODES WERE OBSERVED ALL CAUSED BY OVERSENSING. POCKET MANIPULATION WAS PERFORMED AND THEN NOISE WAS REPRODUCED. LEAD FRACTURE IN THE POCKET SITE WAS THUS SUSPECTED. AN X-RAY ALSO SUGGESTED LEAD FRACTURE IN THE POCKET SITE. A TEMPORARY PACING SYSTEM WAS USED AND THE PACEMAKER WAS PROGRAMMED TO VVI AT 50 BPM UNTIL A LEAD REVISION COULD BE PERFORMED. A WEEK LATER A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375726 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R (B)(4) IPG