BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 4476105 · Received January 29, 2015

    Report

    Report Number
    3008642652-2015-00305
    Event Type
    Death
    Date Received
    January 29, 2015
    Date of Event
    December 26, 2014
    Report Date
    January 21, 2015
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL OF MONITOR SN (B)(4) IS COMPLETE. AS RECEIVED, THE MONITOR WAS FULLY FUNCTIONAL AND ABLE TO DETECT AND TREAT PT. DEVICE EVAL OF ELECTRODE BELT SN (B)(4) IS COMPLETE. AS RECEIVED, THE BELT WAS FULLY FUNCTIONAL AND ABLE TO DETECT AND TREAT A PT. DEVICE MANUFACTURE DATE: MONITOR SN (B)(4) - 01/2012 (REUSE); ELECTRODE BELT SN (B)(4) - 02/2008 (REUSE).

    Description of Event or Problem · 1

    A ZOLL DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PT PASSED AWAY ON (B)(6) 2014. PRIOR TO PASSING, THE PT RECEIVED EIGHT DEFIBRILLATIONS. THE PT'S FIRST FIVE DEFIBRILLATIONS WERE RECEIVED AT 15:22:41, 15:23:36, 15:24:11, 15:32:31 AND 15:33:02. TREATMENTS 1, 4 AND 5 WERE APPROPRIATELY DELIVERED IN RESPONSE TO VENTRICULAR TACHYCARDIA (VT), AND TREATMENTS 2, AND 3 WERE APPROPRIATELY DELIVERED IN RESPONSE TO VENTRICULAR FIBRILLATION (VF). THE PT RECEIVED THREE OTHER TREATMENTS AT 15:33:32, 15:34:05, AND 15:34:30. NON-SUSTAINED VENTRICULAR TACHYCARDIA CONTRIBUTED TO THE FALSE DETECTIONS. VF WITH CPR ARTIFACT WAS DETECTED AT 15:41:57, AND THE DEVICE WAS SHUTDOWN AT 15:53:58. IT WAS REPORTED THAT THE PT WAS OUT SHOPPING AT THE TIME OF THE EVENT BUT BECAME UNCONSCIOUS AT THE TIME OF TREATMENT. CPR ARTIFACT IN THE PT'S ECG STRIPS INDICATES THE PRESENCE OF BYSTANDERS. THE PT PASSED AWAY LATER THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69736 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death