BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 19954615 · Received August 9, 2024

    Report

    Report Number
    3008642652-2024-08185
    Event Type
    Death
    Date Received
    August 9, 2024
    Date of Event
    June 30, 2024
    Report Date
    August 9, 2024
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ELECTRODE BELT AND MONITOR HAVE NOT BEEN RECOVERED. THE DEVICE FLAG DATA FROM THE LAST DOWNLOAD DOES NOT INDICATE ANY DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2024 WHILE REPORTEDLY WEARING THE LIFEVEST. THE PATIENT RECEIVED SEVEN INAPPROPRIATE TREATMENTS. THE DEVICE WAS STARTED UP AT 16:59:26 ON (B)(6) 2024. AT 09:02:26 ON (B)(6) 2024, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS SINUS TACHYCARDIA @ 110 BPM WITH PVC¿S AND MOTION ARTIFACT. AT 09:05:51, THE PATIENT RECEIVED THE FIRST INAPPROPRIATE TREATMENT. RHYTHM AT TIME OF TREATMENT WAS SINUS TACHYCARDIA @ 120 BPM WITH PVC¿S AND MOTION ARTIFACT. POST SHOCK RHYTHM WAS SINUS TACHYCARDIA @ 110 BPM WITH PVC¿S AND MOTION ARTIFACT. AT 09:07:07, THE PATIENT RECEIVED THE SECOND INAPPROPRIATE TREATMENT. RHYTHM AT TIME OF TREATMENT WAS SINUS TACHYCARDIA @ 110 BPM WITH PVC¿S AND MOTION ARTIFACT. POST SHOCK RHYTHM WAS SINUS TACHYCARDIA @ 110 BPM WITH PVC¿S AND MOTION ARTIFACT. AT 09:07:48, THE PATIENT RECEIVED THE THIRD INAPPROPRIATE TREATMENT. RHYTHM AT TIME OF TREATMENT WAS SINUS TACHYCARDIA @ 110 BPM WITH MOTION ARTIFACT. POST SHOCK RHYTHM WAS SINUS TACHYCARDIA @ 110 BPM WITH PVC¿S AND MOTION ARTIFACT. AT 09:08:22, THE PATIENT RECEIVED THE FOURTH INAPPROPRIATE TREATMENT. RHYTHM AT TIME OF TREATMENT WAS SINUS TACHYCARDIA @ 110 BPM WITH PVC¿S AND MOTION ARTIFACT. POST SHOCK RHYTHM WAS SINUS TACHYCARDIA @ 110 BPM WITH PVC¿S AND MOTION ARTIFACT. AT 09:09:01, THE PATIENT RECEIVED THE FIFTH INAPPROPRIATE TREATMENT. RHYTHM AT TIME OF TREATMENT WAS SINUS TACHYCARDIA @ 110 BPM WITH PVC¿S AND MOTION ARTIFACT. POST SHOCK RHYTHM WAS SINUS TACHYCARDIA @ 110 BPM WITH PVC¿S AND MOTION ARTIFACT. AT 09:10:29, THE PATIENT RECEIVED THE SIXTH INAPPROPRIATE TREATMENT. RHYTHM AT TIME OF TREATMENT WAS SINUS TACHYCARDIA @ 120 BPM WITH PVC¿S AND MOTION ARTIFACT. POST SHOCK RHYTHM WAS SINUS TACHYCARDIA @ 110 BPM WITH PVC¿S AND MOTION ARTIFACT. AT 09:11:13, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS SINUS TACHYCARDIA @ 120 BPM WITH PVC¿S AND MOTION ARTIFACT. AT 09:12:37, THE PATIENT RECEIVED THE SEVENTH INAPPROPRIATE TREATMENT. RHYTHM AT TIME OF TREATMENT WAS SINUS TACHYCARDIA @ 120 BPM WITH MOTION ARTIFACT. POST SHOCK RHYTHM WAS SINUS TACHYCARDIA @ 120 BPM WITH PVC¿S AND MOTION ARTIFACT. THE DEVICE WAS SHUT DOWN AT 13:17:23 ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2493536 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death