BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 3484724 · Received November 22, 2013

    Report

    Report Number
    2649622-2013-13600
    Event Type
    Death
    Date Received
    November 22, 2013
    Date of Event
    May 23, 2010
    Report Date
    December 11, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICES ASSOCIATED WITH THIS ADVERSE OUTCOME WERE RETURNED AND THE PATIENT WAS IDENTIFIED AS BEING DECEASED. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. HOWEVER, IF ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. CONCOMITANT MEDICAL PRODUCTS: IMPLANTABLE CARDIO-VERTER DEFIBRILLATOR, PRODUCT ID D284TRK, IMPLANTED: (B)(6) 2009; IMPLANTABLE PACING LEAD: PRODUCT ID 419378, IMPLANTED: (B)(6) 2007; IMPLANTABLE PACING LEAD, PRODUCT ID 5076-52, IMPLANTED: (B)(6) 2009; IMPLANTABLE PACING LEAD, PRODUCT ID 5076-45, IMPLANTED: (B)(6) 2007. (B)(4).

    Additional Manufacturer Narrative · 1

    CLARIFICATION ON DATES FOR THE REPORTED INFORMATION WAS OBTAINED AND NOTED THE BECOMES AWARE DATE AS NOVEMBER 13, 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PRODUCT ID# 694958 - A PROXIMAL PORTION WAS RECEIVED MEASURING 6.5 CM. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND, VISUAL SUMMARY ANALYSIS OF THE LEAD WAS PERFORMED ONLY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIO-VERTER DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED FROM A HISTOLOGIST WITH NO INFORMATION. INFORMATION IDENTIFIED IN THE MANUFACTURE¿S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY NINE MONTHS POST IMPLANT OF THE ICD, APPROXIMATELY 3.5 YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609113 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694958

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Death