BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIFY ASSURA ICD

    MDR report key: 6205113 · Received December 27, 2016

    Report

    Report Number
    2938836-2016-18956
    Event Type
    Death
    Date Received
    December 27, 2016
    Date of Event
    November 1, 2016
    Report Date
    April 27, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P030035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. THE DEVICE WAS INTERROGATED WITH A PROGRAMMER AND HAD NOT REACHED ERI. NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. THE CAUSE OF DEATH WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE DEVICE IS INCLUDED IN THE PREMATURE BATTERY DEPLETION WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ADVISORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856277 UNIFY ASSURA ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3257-40 3888208

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death 1158T/75, (B)(4).| 1788TC/46, (B)(4).| 7020/60, (B)(4).