BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDIS

    MDR report key: 16535877 · Received March 14, 2023

    Report

    Report Number
    1000165971-2023-00141
    Event Type
    Death
    Date Received
    March 14, 2023
    Date of Event
    October 24, 2022
    Report Date
    June 2, 2023
    Manufacturer
    MICROPORT CRM S.R.L.
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO A DEVICE MANUFACTURED BY MICROPORT CRM THAT WAS CLEARED OR APPROVED BY FDA FOR MARKETING IN THE UNITED STATES. PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    Additional Manufacturer Narrative · 0

    THE DEVICE INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO A DEVICE MANUFACTURED BY MICROPORT CRM THAT WAS CLEARED OR APPROVED BY FDA FOR MARKETING IN THE UNITED STATES.

    Description of Event or Problem · 0

    REPORTEDLY, A PATIENT DIDN'T SHOW UP FOR FOLLOW-UP OF APOLLO STUDY M3 ON (B)(6) 2022, RESEARCH OF STUDY-SITE SHOWED THAT PATIENT DIED ON (B)(6) 2022 AT HOME. AS REPORTED THE PATIENT WAS FOUND BY WIFE MOTIONLESS AND REACTIONLESS, NO PULSE RATE WAS DETECTED, DAUGHTER STARTED RESUSCITATION, EMERGENCY TEAM ARRIVED, PATIENT GOT SHOCKED THREE TIMES BY EXTERNAL DEFIBRILLATOR, CPR WAS CONTINUED BY EMERGENCY TEAM, 3 TIMES ADRENALIN AND 2 TIMES AMIODARON WAS GIVEN, VENTRICULAR FIBRILLATION CONTINUOUSLY, ANOTHER 7 SHOCKS DELIVERED BY EXTERNAL DEFIBRILLATOR, CPR STOPPED AFTER 30 MINUTES.

    Description of Event or Problem · 0

    REPORTEDLY, A PATIENT DIDN'T SHOW UP FOR FOLLOW-UP OF APOLLO STUDY M3 ON (B)(6) 2022, RESEARCH OF STUDY-SITE SHOWED THAT PATIENT DIED ON (B)(6) 2022 AT HOME. AS REPORTED THE PATIENT WAS FOUND BY WIFE MOTIONLESS AND REACTIONLESS, NO PULSE RATE WAS DETECTED, DAUGHTER STARTED RESUSCITATION, EMERGENCY TEAM ARRIVED, PATIENT GOT SHOCKED THREE TIMES BY EXTERNAL DEFIBRILLATOR, CPR WAS CONTINUED BY EMERGENCY TEAM, 3 TIMES ADRENALIN AND 2 TIMES AMIODARONE WAS GIVEN, VENTRICULAR FIBRILLATION CONTINUOUSLY, ANOTHER 7 SHOCKS DELIVERED BY EXTERNAL DEFIBRILLATOR, CPR STOPPED AFTER 30 MINUTES,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914530 EDIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MICROPORT CRM S.R.L. EDIS DF4 VR - 2140

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death