BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 9759091 · Received February 26, 2020

    Report

    Report Number
    2649622-2020-04058
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Date of Event
    May 3, 2019
    Report Date
    April 3, 2020
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    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 AND ANALYZED. THE ANALYSIS INDICATED THAT THE PROXIMAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. THE INTERIOR SUPERIOR VENA CAVA DEFIBRILLATION CABLE DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. THE EXPOSED SUPERIOR VENA CAVA DEFIBRILLATION COIL DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. THE ANALYST NOTED THAT THE PROXIMAL CONDUCTOR WAS FRACTURED AT 49 CM THE INTERIOR SUPERIOR VENA CAVA DEFIBRILLATION CABLE WAS FRACTURED AT 39.7 CM AND THE EXPOSED SUPERIOR VENA CAVA DEFIBRILLATION COIL WAS FRACTURED AT 33 CM FROM THE CONNECTOR PIN. CONCOMITANT MEDICAL PRODUCTS: D334DRG ICD, IMPLANTED: (B)(6) 2012. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LEAD WAS PROPHYLACTICALLY EXPLANTED DUE TO THE ADVISORY.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO UNKNOWN REASONS. THE LEAD SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218341 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694958

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR