BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 8086278 · Received November 19, 2018

    Report

    Report Number
    2649622-2018-19016
    Event Type
    Injury
    Date Received
    November 19, 2018
    Date of Event
    October 29, 2018
    Report Date
    November 19, 2018
    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
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS REPORTED AS INCLUDED IN THE FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT CANNOT BE CONFIRMED THAT THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. IT IS INCLUDED IN THE FIELD ACTION IN THE ABUNDANCE OF CAUTION. 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 HAS A DEFIB FRACTURE. SINCE THE PATIENT¿S EF (EJECTION FRACTION) HAS IMPROVED IT WAS DECIDED TO REPROGRAM THE RV LEAD. 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
    923716 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention D334VRG ICD