BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 3241922 · Received July 22, 2013

    Report

    Report Number
    2649622-2013-08239
    Event Type
    Death
    Date Received
    July 22, 2013
    Date of Event
    April 29, 2013
    Report Date
    June 28, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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. ATTEMPT(S) FOR ADDITIONAL INFORMATION REGARDING THE DEATH WITH THE FUNERAL HOME AND THE PHYSICIAN OFFICE WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. CONCOMITANT PRODUCTS: PRODUCT ID D334DRG, IMPLANTED: (B)(6) 2013; PRODUCT ID 5076-52, IMPLANTED: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS ON THREE OCCASIONS. THERE WERE EPISODES OF SHOCKS AND THE PATIENT WAS ADMITTED TWO TIMES TO THE HOSPITAL. THE SPOUSE QUESTIONED IF THE DEVICE OR LEADS WERE MALFUNCTIONING OR IF THE ARRHYTHMIAS WERE CAUSED BY THE DEVICE. THE PATIENT CONTINUES TO FEEL CHEST PAIN. FOLLOW-UP ATTEMPT TO ACQUIRE ADDITIONAL INFORMATION FROM THE CLINIC REPORTED THE PATIENT AS DECEASED WITH NO CAUSE OF DEATH AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340502 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Death