BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCENT DR RF PACEMAKER

    MDR report key: 9110101 · Received September 24, 2019

    Report

    Report Number
    2017865-2019-14091
    Event Type
    Death
    Date Received
    September 24, 2019
    Report Date
    October 8, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    UDI-DI
    05414734503617
    PMA / PMN Number
    P030035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED DUE TO DECEASED PATIENT. THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED. CONCOMITANT MEDICAL PRODUCTS: TENDRIL SDX LEAD, TENDRIL SDX LEAD.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2019-14092, 2938836-2019-13934. IT WAS REPORTED THE PATIENT DECEASED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904874 ACCENT DR RF PACEMAKER IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2210 3397070 05414734503617

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death