BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 6007842 · Received October 6, 2016

    Report

    Report Number
    6000023-2016-00013
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    August 5, 2015
    Report Date
    September 30, 2019
    Manufacturer
    MEDTRONIC, B.V.
    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

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. SINCE (B)(4) 2016, THERE WERE 223253 SHORT CIRCUIT PACES AND 36 NON-PHYSIOLOGICAL PACES WITH 17884 SUCCESSFUL PACES. THE RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE TREND WAS DISABLED. THE LIFE TIME MINIMUM RV PACING IMPEDANCE WAS 226 OHMS AND LIFETIME MAXIMUM WAS 299 OHMS. THE RV IMPEDANCE WAS 285 OHMS AT IMPLANT.

    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 OF THE RIGHT VENTRICULAR PACING LEAD WAS BELOW THE EXPECTED LOWER RANGE. 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 THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW PACING IMPEDANCE. DUE TO A DECREASE IN THE LEAD IMPEDANCE, THE LEAD WAS SWITCHED FROM BIPOLAR CONFIGURATION TO UNIPOLAR. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658792 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, B.V. 4024-58

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention 4524-53 LEAD