BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 1791669 · Received August 10, 2010

    Report

    Report Number
    2649622-2010-06969
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    December 2, 2009
    Report Date
    November 9, 2018
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. IT SHOWED A MEASUREMENT SYSTEM LOCK-UP, RESULTING IN AN UNCLEARABLE ERI (ELECTIVE REPLACEMENT INDICATOR). A SINGLE UNIT WAS REPAIRED BUT NO OTHER DEVICES WERE REPAIRED.

    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 DURING INTERROGATION OF THE DEVICE, THE DEVICE APPEARED TO HAVE REACHED ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE HAD "FROZEN" AT VVI AT 65PPM. THE BATTERY VOLTAGE AND IMPEDANCE COULD NOT BE MEASURED. A CUSTOM SOFTWARE DOWNLOAD WAS SUCCESSFUL IN CORRECTING THE ISSUE. THE DEVICE WAS REPROGRAMMED TO THE PATIENT'S INITIAL MODE AND ALL TESTING PERFORMED. ATRIAL LEAD THRESHOLDS WERE HIGH AND COULD NOT BE MEASURED, AND THERE WAS INTERMITTENT CAPTURE IN BOTH POLARITIES. THE ATRIAL CAPTURE MANAGEMENT TREND REPORT INDICATED THE ATRIAL LEAD THRESHOLDS HAD BEEN CONSISTENTLY HIGH. FURTHER REPROGRAMMING WAS DONE, AND THE DEVICE AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED RE-OCCURRENCE OF RIGHT ATRIAL (RA) LEAD HIGH THRESHOLD BUT IMPEDANCE NORMAL AND STABLE AND SENSING ACCEPTABLE RANGE. THE DEVICE SETTINGS HAD BEEN RE-PROGRAMMED, AND THE LEAD REMAINS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4574 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention 4074 IMPLANTABLE PACING LEAD