BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6139172 · Received December 1, 2016

    Report

    Report Number
    3008642652-2016-08849
    Event Type
    Death
    Date Received
    December 1, 2016
    Date of Event
    November 4, 2016
    Report Date
    December 1, 2016
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) HAVE NOT YET BEEN RETURNED FROM THE FIELD. DEVICE EVALUATION OF THE ELECTRODE BELT INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT. THE REVIEW OF THE SOFTWARE FLAGS CONSISTED OF AN ANALYSIS OF THE DOWNLOADED DATA TO IDENTIFY ANY FAULT FLAGS OR UNUSUAL PATTERNS OF SOFTWARE FLAGS. THE SOFTWARE FLAG FILES DID NOT SUGGEST A DEVICE MALFUNCTION THAT WOULD CONTRIBUTE TO THE PATIENT'S DEATH. DEVICE MANUFACTURE DATE: MONITOR: SN (B)(4) : 9/16/2014. ELECTRODE BELT: SN (B)(4) :7/31/2014.

    Description of Event or Problem · 1

    A U.S. DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT HAD PASSED AWAY WHILE WEARING THE LIFEVEST. PRIOR TO PASSING, THE PATIENT RECEIVED TWO APPROPRIATE TREATMENTS. AT 1:18:12 ON (B)(6 2016, THE PATIENT RECEIVED A TREATMENT. THE PATIENT'S RHYTHM WAS VENTRICULAR FIBRILLATION (VF) AT THE TIME OF THE TREATMENT. THE POST-SHOCK RHYTHM WAS ALSO VF. AT 1:20:25 THE PATIENT RECEIVED A SECOND TREATMENT DURING VF. THE POST-SHOCK RHYTHM WAS ASYSTOLE. THE PATIENT REMAINED IN ASYSTOLE. THE PATIENT PASSED AWAY ON (B)(6) 2016. POST-SHOCK ASYSTOLE IS A KNOWN AND POTENTIALLY ADVERSE OUTCOME OF DEFIBRILLATION THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789251 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    0 55 YR Death
    1 55 YR Death