BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 5017936 · Received August 20, 2015

    Report

    Report Number
    2649622-2015-10600
    Event Type
    Death
    Date Received
    August 20, 2015
    Date of Event
    June 17, 2015
    Report Date
    August 4, 2015
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINED THAT THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. CONCOMITANT MEDICAL DEVICES: 419488, LEAD, IMPLANTED: (B)(6) 2005; 5076-52, LEAD, IMPLANTED: (B)(6) 2004. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT'S PHYSICIAN WHICH NOTED THAT THE CAUSE OF DEATH WAS HEART FAILURE. THE PHYSICIAN ALSO INDICATED THAT DEVICE TACHY THERAPIES HAD BEEN DEACTIVATED BEFORE THE PATIENT'S DEATH, THAT THE DEVICE SYSTEM WAS FUNCTIONING NORMALLY SHORTLY BEFORE THE PATIENT DIED, AND THAT THE DEATH WAS NOT RELATED TO THE DEVICE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS DECEASED. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY 4 MONTHS AFTER IMPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), APPROXIMATELY 9.5 YEARS AFTER IMPLANT OF THE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD, AND APPROXIMATELY 10.5 YEARS AFTER IMPLANT OF THE RIGHT ATRIAL (RA) LEAD. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550851 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Death