BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3991123 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08313
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 24, 2021
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED GRADUALLY INCREASING IMPEDANCE OVER TIME ON THE RV AND SUPERIOR VENA CAVA (SVC) HIGH VOLTAGE PORTIONS OF THE LEAD. THE RV LEAD IMPEDANCE ALERTS WERE REPROGRAMMED AND THE 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
    466932 SPRINT FIDELIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Hospitalization| R 7232CX ICD (B)(6) 2006| 7232CX ICD (B)(6) 2006