BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 3990358 · Received August 7, 2014

    Report

    Report Number
    3008973940-2014-00284
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P830061
    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 THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT: 4074-52 LEAD IMPLANTED 2013-(B)(6). (B)(4).

    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

    PRODUCT EVENT SUMMARY:THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA WAS RECEIVED AND ANALYZED AND INDICATED THE IMPEDANCE ON THE ATRIAL PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. WEEKLY PACING IMPEDANCE TREND DATA SHOWS ATRIAL BIPOLAR AND UNIPOLAR IMPEDANCE HAS BEEN VARYING THROUGHOUT THE RECORD. IMPEDANCE MEASUREMENTS OF GREATER THAN 2000 OHMS BEGAN IN (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD EXHIBITED HIGH IMPEDANCE SINCE IMPLANT. AT A ROUTINE FOLLOW-UP, FLUCTUATIONS WERE ALSO OBSERVED IN THE LEAD IMPEDANCE TREND FOR BOTH UNIPOLAR AND BIPOLAR. A FAILURE TO PACE AT MAXIMUM OUTPUT WAS SEEN WHILE NOISE AND UNDERSENSING OF P-WAVES WERE ALSO OBSERVED. A LEAD FRACTURE IS SUSPECTED. LEAD SENSITIVITY WAS ADJUSTED AND THE LEAD REMAINS IN USE. IT WAS DECIDED TO MONITOR THE PATIENT FOR THREE MONTHS WITH MINIMUM OUTPUT AND MAXIMUM SENSING SENSITIVITY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463640 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 457445

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention A3DR01 IPG