BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTISENSE

    MDR report key: 3791342 · Received May 5, 2014

    Report

    Report Number
    2017865-2014-11997
    Event Type
    Death
    Date Received
    May 5, 2014
    Date of Event
    September 28, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    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 HAS DECEASED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267139 OPTISENSE PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 1999/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death PM2210, 71093502088TC/52, BER037535