BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 4121051 · Received September 26, 2014

    Report

    Report Number
    2649622-2014-10380
    Event Type
    Death
    Date Received
    September 26, 2014
    Date of Event
    August 8, 2014
    Report Date
    October 23, 2014
    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

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED. VISUAL ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    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: DTBA1D1, ICD, IMPLANTED: (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN A FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION.

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED FROM A FUNERAL HOME WITH NO INFORMATION. INFORMATION IDENTIFIED IN THE ONLINE OBITUARY INDICATED THE PATIENT DIED APPROXIMATELY 10 MONTHS POST IMPLANT OF THE ICD AND 9 YEARS POST IMPLANT OF THE LEADS. IT WAS REPORTED THAT THE CAUSE OF DEATH LISTED ON THE DEATH CERTIFICATE IS CARDIAC DYSRHYTHMIA SECONDARY TO CORONARY ARTERY DISEASE, DIABETES MELLITUS AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600590 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Death 419378 LEAD, 5076-52 LEAD