BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREEPI

    MDR report key: 4232889 · Received November 6, 2014

    Report

    Report Number
    2649622-2014-12996
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 12, 2014
    Report Date
    April 29, 2019
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (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 OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER), AND INDICATED THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT (LIA). THE LIA WAS TRIGGERED FOR TWO OR MORE VENTRICULAR TACHYCARDIA NONSUSTAINED EPISODES LESS THAN 220 MILLISECONDS AND INCREASED SIC.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    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 THERE WERE EPISODES OF NOISE OBSERVED ON THE ATRIAL AND VENTRICULAR CHANNELS AT DIFFERENT TIMES AND ON DIFFERENT DAYS. ISOMETRICS WERE PERFORMED, NO NOISE WAS SEEN AND THRESHOLDS AND IMPEDANCE LEVELS WERE WITHIN NORMAL LIMITS. ADDITIONAL INFORMATION WAS RECEIVED AND REPORTED THAT APPROXIMATELY TWO WEEKS LATER, ISOMETRICS WERE COMPLETED AND NOISE WAS SEEN ON BOTH THE ATRIAL AND VENTRICULAR CHANNELS. A LEAD INTEGRITY ALERT WAS TRIGGERED FOR NON-SUSTAINED TACHYCARDIA AND SHORT INTERVAL COUNTS (SIC). IT WAS FURTHER REPORTED THAT ELECTROMAGNETIC INTERFERENCE IS A POSSIBLE SOURCE OF THE NOISE. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED HISTORY OF VENTRICULAR OVERSENSING AND WELL AS ATRIAL OVERSENSING. THE LEADS REMAIN IN USE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE LEAD NOISE WAS SUSPECTED TO BE DUE TO LEAD/LEAD INTERACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712808 CAPSUREEPI ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4968-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00013 YR D314DRG ICD, 4968-25 LEAD, 6937A-35 LEAD