BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3279669 · Received August 10, 2013

    Report

    Report Number
    2649622-2013-10132
    Event Type
    Injury
    Date Received
    August 10, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCTS: PRODUCT ID UNK-COMP-ICD, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013; PRODUCT ID 5554-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN IMPLANTED WITH A MEDTRONIC DEVICE WHICH WAS REPLACED WITH A COMPETITOR DEVICE DUE TO TWOS(T WAVE OVERSENSE) ACTIVATION (TWOS COULDN¿T BE AVOIDED). SHOCKS OCCURRED DUE TO NOISE OR MYOGENIC POTENTIAL. THE RV (RIGHT VENTRICULAR) LEAD WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384947 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694958

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R