BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTISENSE

    MDR report key: 2842465 · Received November 21, 2012

    Report

    Report Number
    2017865-2012-10488
    Event Type
    Death
    Date Received
    November 21, 2012
    Date of Event
    August 10, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD DECEASED IN HIS SLEEP. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL SUGGESTING THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTISENSE PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1699TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death 3207, (B)(4), 7121, (B)(4), 1156, (B)(4)