BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREEPI

    MDR report key: 5893740 · Received August 22, 2016

    Report

    Report Number
    2182208-2016-02174
    Event Type
    Injury
    Date Received
    August 22, 2016
    Date of Event
    July 26, 2016
    Report Date
    August 2, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. THE ANALYST COMMENTED THAT ON (B)(4) 2016 THE MAX RV PACING IMPEDANCE MEASURED 20365 OHMS UP FROM A TREND OF 231-348 OHMS. SINCE (B)(4) 2016 THERE WERE 755353 OPEN CIRCUIT COUNTS. LEAD SET TO UNIPOLAR. NO RV CAPTURE THRESHOLD DATA AVAILABLE. NO RV OVERSENSING WAS OBSERVED IN SAVE TO DISK EGMS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 4965-25 LEAD, IMPLANTED: (B)(6) 2006; PB1018 TRANSCATHETER VALVE IMPLANTED: (B)(6) 2016.

    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 PATIENT'S RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS EXHIBITED HIGH THRESHOLDS, NO CAPTURE, AND HIGH IMPEDANCE. IT WAS ALSO REPORTED THAT AN X-RAY SHOWED DISCONTINUITY OF THE LEAD CONDUCTORS BELOW THE HEART. THE RA AND RV LEADS WERE CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546897 CAPSUREEPI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC, INC. 4965-25

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| R