BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASSURITY RF DR

    MDR report key: 6141723 · Received December 2, 2016

    Report

    Report Number
    2017865-2016-07519
    Event Type
    Death
    Date Received
    December 2, 2016
    Date of Event
    October 26, 2016
    Report Date
    November 7, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    PMA / PMN Number
    P970013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    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
    791473 ASSURITY RF DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2240 A000008237

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death 2088TC/52, (B)(4)| 2088TC/58, (B)(4)