BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3616328 · Received February 8, 2014

    Report

    Report Number
    2182208-2014-00386
    Event Type
    Injury
    Date Received
    February 8, 2014
    Report Date
    November 13, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0069-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 PRODUCTS: ICM09JB45 IMPLANTABLE PACING LEAD (B)(6) 2005-11; 7278 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SUSPECTED INFECTIVE ENDOCARDITIS WITH A PULMONARY EMBOLUS. THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) AND LEADS WERE REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SUSPECTED INFECTIVE ENDOCARDITIS WITH A PULMONARY EMBOLUS. THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) AND LEADS WERE REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83842 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 694858

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Hospitalization| R