BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 4160918 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11711
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    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. PRODUCT EVENT SUMMARY: A FULL LEAD WAS RECEIVED IN SEGMENTS AND ANALYZED. ANALYSIS REVEALED THAT THE RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND GRADUAL RISING IMPEDANCE ON THE LOW-VOLTAGE PORTION OF THE LEAD. THE RV 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
    641792 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694958

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R D154VRC ICD 2006