BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 9617619 · Received January 22, 2020

    Report

    Report Number
    2649622-2020-01771
    Event Type
    Injury
    Date Received
    January 22, 2020
    Date of Event
    January 6, 2020
    Report Date
    February 6, 2020
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DISTAL PORTION OF THE LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. VISUAL ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. 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 VENTRICULAR (RV) LEAD WAS SUSPECTED TO HAVE FRACTURED DUE TO LOSS OF CAPTURE, NOISE AND HIG H/UNDEFINED PACING IMPEDANCE VALUES. THE LEAD WAS EXPLANTED 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
    82099 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R