BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3991325 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08187
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 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
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. CONCOMITANT MEDICAL PRODUCTS: 3830 IMPLANTABLE PACING LEAD, IMPLANTED (B)(6) 2009; 4194 IMPLANTABLE PACING LEAD, IMPLANTED (B)(6) 2009; 4076 IMPLANTABLE PACING LEAD, IMPLANTED (B)(6) 2006; 6949 IMPLANTABLE TACHY LEAD, IMPLANTED (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT T-WAVE OVERSENSING (TWOS) OCCURRED IN THE BIPOLAR (SENSE POLARITY) MODE AT 0.3 MILLIVOLT SENSITIVITY. IT WAS ALSO REPORTED THAT CHANGING TO A LOWER SENSITIVITY APPEARS TO RESOLVE THE TWOS ISSUE. 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
    467433 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694958

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention D284TRK ICD