BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5070960 · Received September 11, 2015

    Report

    Report Number
    3008642652-2015-05523
    Event Type
    Death
    Date Received
    September 11, 2015
    Date of Event
    August 5, 2015
    Report Date
    September 9, 2015
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON RECEIPT THE MONITOR WAS FULLY FUNCTIONAL. TESTING VERIFIED PROPER FUNCTIONALITY OF THE EQUIPMENT'S ECG ACQUISITION AND PULSE DELIVERY CIRCUITRY. BATTERY SN (B)(4) WAS RETURNED TO THE DISTRIBUTOR FOR EVALUATION. THE EVALUATION DID NOT INDICATE ANY DEVICE MALFUNCTION. AS RECEIVED THE BATTERY WAS ABLE TO POWER ON A MONITOR AND CHARGE. THE BATTERY PACK POWERED THE PATIENT'S MONITOR FOR 43 HOURS BETWEEN (B)(6) 2015. PATIENTS ARE INSTRUCTED TO EXCHANGE AND RECHARGE THE BATTERY PACK EVERY 24 HOURS. NOTIFICATIONS ARE PROVIDED TO THE PATIENT TO REPLACE THE BATTERY WHEN THE BATTERY PACK CAPACITY RUNS LOW. THE BATTERY PACK OPERATED AS DESIGNED AND MET ITS PERFORMANCE SPECIFICATIONS. DEVICE EVALUATION OF BELT SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE CABLE CONNECTING THE DISTRIBUTION NODE AND THE REAR THERAPY ELECTRODE WAS PULLED FROM THE STRAIN RELIEF. THE ROOT CAUSE OF THE PULLED CABLE IS EXCESSIVE FORCE ON THE CABLE SECTION. THERE IS NO INDICATION THAT THE DAMAGE WAS PRESENT WHILE THE DEVICE WAS MONITORING THE PATIENT, PRIOR TO THE PATIENT'S DEATH. THE DEVICE IS DESIGNED TO ALARM AND STORE FLAGS IN THE EVENT OF DAMAGE TO THE PULSE DELIVERY CIRCUITRY. THERE IS NO EVIDENCE IN THE FLAGS OF AN ISSUE WITH BELT. THERE IS NO INFORMATION AT THIS TIME TO REASONABLY SUGGEST THAT THE LIFEVEST CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THE PATIENT WAS IN SVT AT 180 BPM AT THE TIME THE DEVICE WAS SHUT DOWN. THERE IS NO INDICATION THAT THE DAMAGED BELT CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. DEVICE MANUFACTURE DATE AND USAGE OF DEVICE: MONITOR SN (B)(4): 04/03/2015 - INITIAL USE; BELT SN (B)(4): 03/06/2015 - INITIAL USE; BATTERY SN (B)(4): 04/30/2014 - REUSE.

    Description of Event or Problem · 1

    A DISTRIBUTOR NOTIFIED ZOLL ON 08/14/2015 THAT A (B)(6) MALE PATIENT HAD DIED. THE PATIENT WAS FOUND ALONE THE MORNING OF (B)(6) 2015. PER REVIEW OF THE PATIENT'S DOWNLOADED FLAG FILES, THE PATIENT RECEIVED RUNTIME EXPIRED FLAGS THE MORNING OF (B)(6) 2015. THE FLAGS SHOWED THAT BATTERY SN (B)(4) WAS PLACED INTO THE MONITOR ON (B)(6) 2015 AT 3:08 PM. ON (B)(6) 2015 AT 4:14AM, AFTER 37 HOURS OF USE, THE DEVICE RECORDED THE FIRST RUNTIME EXPIRED FLAG. THERE WERE NO SERIOUS FAULT FLAGS RECORDED DURING THE FIRST 37 HOURS OF USE. THE DEVICE CONTINUED TO MONITOR THE PATIENT FOR 6 ADDITIONAL HOURS. THE DEVICE NOTIFIED THE PATIENT TO REPLACE THE BATTERY PACK EVERY 15 MINUTES UNTIL THE DEVICE ABNORMALLY SHUTDOWN AT 10:15AM AFTER 43 HOURS OF USE. REVIEW OF THE PATIENT'S LONG TERM ECG RECORDINGS REVEALED THAT THE PATIENT WAS IN SVT AT 180BPM AT THE TIME THAT THE DEVICE WAS DEACTIVATED. THERE WERE NO ARRHYTHMIA DETECTIONS OR AUTOMATIC ECG RECORDINGS WHILE MONITORING THE PATIENT. THERE WERE NO ALLEGED DEFICIENCIES AGAINST THE DEVICE. THE PATIENT'S MONITOR AND ELECTRODE BELT WERE RETURNED TO ZOLL MANUFACTURING FOR INVESTIGATION. UPON RECEIPT, BELT SN (B)(4) HAD A PULLED CABLE. PER REVIEW OF THE PATIENT'S FLAGS, THERE IS NO INDICATION THAT THE DEVICE WAS DAMAGED WHILE MONITORING THE PATIENT. THERE IS NO INDICATION AT THIS TIME TO SUGGEST THAT THE LIFEVEST CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602967 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death