BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPUS

    MDR report key: 6927210 · Received October 7, 2017

    Report

    Report Number
    1000165971-2017-00739
    Event Type
    Death
    Date Received
    October 7, 2017
    Date of Event
    March 30, 1990
    Report Date
    September 8, 2017
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    LWW
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY, PATIENT DIED FROM UNKNOWN CAUSES ON (B)(6) 1990. IT IS UNKNOWN WHETHER THE DEVICE WAS EXPLANTED OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706442 OPUS SINGLE-CHAMBER PACEMAKER LWW SORIN GROUP ITALIA S.R.L. - CRM FACILITY OPUS 4024

    Patients

    Seq Age Sex Outcome Treatment
    1 Death