BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECHOMARK LP

    MDR report key: 11646254 · Received April 9, 2021

    Report

    Report Number
    3014680735-2021-00002
    Event Type
    Death
    Date Received
    April 9, 2021
    Date of Event
    January 23, 2020
    Report Date
    February 26, 2021
    Manufacturer
    SONAVEX, INC.
    Product Code
    NEU
    UDI-DI
    B53620001
    PMA / PMN Number
    K180621
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMMUNICATION INITIALLY RECEIVED THROUGH STUDY STATED THE EVENT WAS UNRELATED TO THE DEVICE AND UNRELATED TO STUDY. NEW INFORMATION RECEIVED FROM THE INVESTIGATOR ON 1/28/2021 INDICATED POSSIBLE DEVICE INVOLVEMENT BASED ON OCCURRENCE IN 30 DAY POST-OPERATIVE WINDOW AND LACK OF EXPLICIT EXCLUSIONARY EVIDENCE. NO AUTOPSY WAS PERFORMED. CAUSE OF DEATH IS UNKNOWN. NO EVIDENCE OF DEVICE INVOLVEMENT OR MALFUNCTION PROVIDED.

    Description of Event or Problem · 1

    PATIENT DEATH REPORTED TO HAVE OCCURRED IN 30 DAY POSTOPERATIVE WINDOW. CAUSE OF DEATH UNKNOWN. NO INDICATION OF IMPLANT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542626 ECHOMARK LP IMPLANTABLE RADIOGRAPHIC MARKER NEU SONAVEX, INC. 2000 P-14526 B53620001

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death