BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTISENSE LEAD

    MDR report key: 6002899 · Received October 6, 2016

    Report

    Report Number
    2938836-2016-11938
    Event Type
    Death
    Date Received
    October 6, 2016
    Date of Event
    November 2, 2015
    Report Date
    September 13, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658869 OPTISENSE LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1999/52 3720823

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death (B)(4)| (B)(4)| (B)(4)