BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMBLEM S-ICD

    MDR report key: 16372484 · Received February 14, 2023

    Report

    Report Number
    2124215-2023-06537
    Event Type
    Death
    Date Received
    February 14, 2023
    Date of Event
    February 6, 2023
    Report Date
    March 8, 2023
    Manufacturer
    OSCOR INC
    Product Code
    LWS
    UDI-DI
    00802526585968
    PMA / PMN Number
    P110042/S043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS ELECTRODE WENT INTO CARDIAC ARREST AND HAD RECEIVED MULTIPLE INAPPROPRIATE SHOCKS DUE TO T-WAVE OVERSENSING. THE FOURTH SHOCK OF THIS EPISODE ACCELERATED THE PATIENT'S RHYTHM INTO VENTRICULAR FIBRILLATION (VF) WHICH WAS UNSUCCESSFULLY TREATED WITH THE FIFTH SHOCK. NO FURTHER SHOCKS WERE DELIVERED BY THE SYSTEM AS THERAPY HAD BEEN EXHAUSTED IN THIS EPISODE, AND THE VF CONTINUED. CARDIOPULMONARY RESUSCITATION WAS ADMINISTERED; HOWEVER, THE PATIENT EVENTUALLY PASSED AWAY DUE TO ANOXIC ENCEPHALOPATHY. AN X-RAY TAKEN LAST YEAR SHOWED THE ELECTRODE HAD MOVED INTO A SUB-OPTIMAL POSITION AS THE PATIENT HAD TWIDDLED THEIR SYSTEM, WHICH MAY HAVE AFFECTED THE ELECTRODE'S ABILITY TO SENSE AND DELIVER THERAPY APPROPRIATELY. THE ELECTRODE WAS BURIED WITH THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE INAPPROPRIATE SHOCKS DUE TO T-WAVE OVERSENSING. IT WAS DIFFICULT TO CONVERT THE ARRHYTHMIA. ONE OF THE SHOCKS INDUCED AN ARRHYTHMIA. THE PATIENT RECEIVED CPR. AN X-RAY WAS REVIEWED, AND THE DEVICE AND ELECTRODE APPEARED TO HAVE BEEN TWIDDLED (MOVED BY THE PATIENT). THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE SYSTEM REMAINS IMPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS ELECTRODE WENT INTO CARDIAC ARREST AND HAD RECEIVED MULTIPLE INAPPROPRIATE SHOCKS DUE TO T-WAVE OVERSENSING. THE FOURTH SHOCK OF THIS EPISODE ACCELERATED THE PATIENT'S RHYTHM INTO VENTRICULAR FIBRILLATION (VF) WHICH WAS UNSUCCESSFULLY TREATED WITH THE FIFTH SHOCK. NO FURTHER SHOCKS WERE DELIVERED BY THE SYSTEM AS THERAPY HAD BEEN EXHAUSTED IN THIS EPISODE, AND THE VF CONTINUED. CARDIOPULMONARY RESUSCITATION WAS ADMINISTERED; HOWEVER, THE PATIENT EVENTUALLY PASSED AWAY DUE TO ANOXIC ENCEPHALOPATHY. AN X-RAY TAKEN LAST YEAR SHOWED THE ELECTRODE HAD MOVED INTO A SUB-OPTIMAL POSITION AS THE PATIENT HAD TWIDDLED THEIR SYSTEM, WHICH MAY HAVE AFFECTED THE ELECTRODE'S ABILITY TO SENSE AND DELIVER THERAPY APPROPRIATELY. THE ELECTRODE WAS BURIED WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721683 EMBLEM S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS OSCOR INC 3401 A142283 00802526585968

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention| L| D| H