BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3924766 · Received June 30, 2014

    Report

    Report Number
    3008642652-2014-01991
    Event Type
    Death
    Date Received
    June 30, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 26, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY. DEVICE EVALUATION OF BELT SN (B)(4) IS COMPLETE. AS RECEIVED THE BELT WAS ABLE TO DETECT AND TREAT. DEVICE EVALUATION OF MONITOR SN (B)(4) HAS NOT YET BEEN COMPLETED. THERE IS NO EVIDENCE AVAILABLE AT THIS TIME TO SUGGEST THE DEVICE WAS UNABLE TO DETECT AND TREAT WHILE IN USE. A SUPPLEMENTAL REPORT WILL BE SENT IF A DEFICIENCY IS IDENTIFIED UPON EVALUATION. VENTRICULAR TACHYCARDIA (VT) AT 136 BPM WAS DETECTED AT 05:05:38 ON (B)(4) 2014. THE LIFEVEST DELIVERED AN APPROPRIATE TREATMENT IN RESPONSE TO THE ARRHYTHMIA AT 04:06:16 WITH A POST SHOCK RHYTHM OF VT AT 122 BPM. THE LIFEVEST DELIVERED TWO OTHER TREATMENTS IN RESPONSE TO CPR ARTIFACT. THE POST SHOCK RHYTHMS WERE CPR ARTIFACT WITH PERIODS OF ASYSTOLE AND SEVERE BRADYCARDIA RESPECTIVELY. THE PATIENT PASSED AWAY AROUND 4:30:00 ON (B)(6) 2014 WHILE IN THE HOSPITAL. THE PATIENT WAS WEARING THE DEVICE AT TIME OF DEATH. REVIEW OF THE PATIENT'S FLAGS AND ECG STRIPS SUGGESTS THAT THE LIFEVEST WAS ABLE TO DETECT AND TREAT WHILE IN USE. NO DEFICIENCIES WERE ALLEGED AGAINST THE DEVICE.

    Description of Event or Problem · 1

    ZOLL LOGISTICS CONTACTED ZOLL CUSTOMER SUPPORT ON (B)(4) 2014 TO REPORT THAT A (B)(6) YEAR OLD MALE PATIENT PASSED AWAY AT THE HOSPITAL ON (B)(6) 2014. PRIOR TO PASSING, THE PATIENT RECEIVED THREE TREATMENT SHOCKS. NO DEFICIENCIES WERE ALLEGED AGAINST THE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378670 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death