BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTEGRITY MICRO

    MDR report key: 5029246 · Received August 25, 2015

    Report

    Report Number
    2017865-2015-27903
    Event Type
    Death
    Date Received
    August 25, 2015
    Date of Event
    October 10, 2005
    Report Date
    August 18, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    PMA / PMN Number
    P880086
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561727 INTEGRITY MICRO IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 5336 0002271409

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death