BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3861540 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07234
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    February 19, 2014
    Report Date
    April 9, 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
    NY, US
    Reporter Occupation
    ATTORNEY

    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: 4076 IMPLANTABLE PACING LEAD, IMPLANTED (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED PERSONAL INJURIES DUE TO A IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MALFUNCTION. THE ICD WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS DEFECTIVE. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342191 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694958

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R D274DRG ICD