MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM; WEARABLE CARDIOVERTER DEFIBRILLATOR

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Bradycardia (1751); Tachycardia (2095); Ventricular Fibrillation (2130); Shock from Patient Lead(s) (3162); Heart Block (4444)

Event Date 08/27/2021

Event Type  Death  

Event Description

A us distributor contacted zoll to report that a patient passed away.The patient's date of passing was not reported.Review of the patient's download data indicates the patient received thirty one appropriate shocks and three inappropriate shocks in response to nsvt during the last wear time.Reporting event out of an abundance of caution as the date of passing was not reported and the patient received 3 inappropriate shocks during the last wear time.The device was started up at 20:02:10 on (b)(6) 2021.The patient was in sinus rhythm at 60 bpm at 22:07:58 on (b)(6) 2021.The patient's rhythm then transitioned to vt at 260 bpm with motion artifact.The patient received the first appropriate shock at 22:08:34.The patient's rhythm at the time of the shock was vf.The patient's post-shock rhythm was sinus bradycardia at 40 bpm.The patient received the second appropriate shock at 23:15:12.The patient's rhythm at the time of the shock was vt at 240 bpm.The patient's post-shock rhythm was sinus bradycardia at 40 bpm.The patient received the third and fourth appropriate shocks at 23:20:30 and 23:24:33.The patient's rhythm at the time of each shock was vt at 250 bpm.The patient's post-shock rhythms were sinus bradycardia at 50 bpm and sinus bradycardia at 40 bpm respectively.The patient received the fifth and sixth appropriate shocks at 23:38:40 and 23:44:48.The patient's rhythm at the time of each shock was vt at 250 bpm.The patient's post-shock rhythms were sinus bradycardia at 50 bpm and sinus bradycardia at 40 bpm respectively.The patient received the seventh and eighth appropriate shocks at 23:49:00 and 23:53:06.The patient's rhythm at the time of each shock was vt at 280 bpm.The patient's post-shock rhythm for each shock was sinus bradycardia at 50 bpm.The patient received the ninth appropriate shock at 23:57:57.The patient's rhythm at the time of the shock was vt at 250 bpm.The patient's post-shock rhythm was sinus bradycardia at 50 bpm.The patient received the tenth appropriate shock at 00:01:49 on (b)(6) 2021.The patient's rhythm at the time of the shock was vt at 240 bpm.The patient's post-shock rhythm was sinus bradycardia at 50 bpm.The patient received the eleventh appropriate shock at 00:06:03.The patient's rhythm at the time of the shock was vf.The patient's post-shock rhythm was sinus bradycardia at 50 bpm.The patient received the twelfth appropriate shock at 00:10:28.The patient's rhythm at the time of the shock was vt at 260 bpm.The patient's post-shock rhythm was sinus bradycardia at 50 bpm.The patient received the thirteenth appropriate shock at 00:14:29.The patient's rhythm at the time of the shock was vt at 250 bpm.The patient's post-shock rhythm was sinus bradycardia at 50 bpm.The patient received the fourteenth appropriate shock at 00:17:50.The patient's rhythm at the time of the shock was vt at 240 bpm.The patient's post-shock rhythm was sinus bradycardia at 50 bpm.The patient received the fifteenth appropriate shock at 00:21:32.The patient's rhythm at the time of the shock was vf.The patient's post-shock rhythm was sinus bradycardia at 50 bpm.The patient received the sixteenth and seventeenth appropriate shocks at 00:24:28 and 00:27:21.The patient's rhythm at the time of each shock was vt at 260 bpm.The patient's post-shock rhythm of each shock was sinus bradycardia at 50 bpm.The patient received the eighteenth appropriate shock at 00:29:41.The patient's rhythm at the time of the shock was vf.The patient's post-shock rhythm was sinus bradycardia at 50 bpm with motion artifact.The patient received the nineteenth appropriate shock at 00:32:10.The patient's rhythm at the time of the shock was vt at 240 bpm.The patient's post-shock rhythm was sinus bradycardia at 50 bpm.The patient received the twentieth appropriate shock at 00:34:13.The patient's rhythm at the time of the shock was vf.The patient's post-shock rhythm was sinus bradycardia at 50 bpm.The patient received the twenty-first appropriate shock at 00:36:44.The patient's rhythm at the time of the shock was vt at 260 bpm.The patient's post-shock rhythm was sinus bradycardia at 50 bpm.The patient received the twenty-second, twenty-third, and twenty-fourth appropriate shocks at 00:38:46, 00:40:59, and 00:42:46.The patient's rhythm at the time of each shock was vt at 250 bpm.The patient's post-shock rhythms were sinus bradycardia at 50 bpm, sinus rhythm at 60 bpm, and sinus bradycardia at 50 bpm respectively.The patient received the twenty-fifth appropriate shock at 00:44:52.The patient's rhythm at the time of the shock was vt at 230 bpm.The patient's post-shock rhythm was sinus bradycardia at 50 bpm.The device was shutdown at 00:48:13 on (b)(6) 2021.The device was started up again at 00:49:05.The patient was in sinus rhythm at 60 bpm with nsvt and pvc's at 03:42:01.The patient's rhythm transitioned to vt at 210 bpm at 03:43:27.The patient received the twenty-sixth appropriate shock at 03:43:58.The patient's rhythm at the time of the shock was vt at 210 bpm.The patient's post-shock rhythm was sinus bradycardia at 50 bpm with bbb.The patient received the twenty-seventh appropriate shock at 03:47:30.The patient's rhythm at the time of the shock was vt at 220 bpm.The patient's post-shock rhythm was sinus rhythm at 60 bpm.The patient was in sinus rhythm at 60 bpm with nsvt at 03:49:24.The patient received the first inappropriate shock at 03:49:56.The patient's rhythm at the time of the shock was nsvt.The patient's post-shock rhythm was sinus rhythm at 60 bpm.The patient received the second inappropriate shock at 03:52:12.The patient's rhythm at the time of the shock was nsvt.The patient's post-shock rhythm was sinus rhythm at 60 bpm with nsvt.The patient's rhythm transitioned to vt at 230 bpm at 03:53:51.The patient received the twenty-eighth and twenty-ninth appropriate shocks at 03:54:22 and 03:59:40.The patient's rhythm at the time of each shock was vt at 220 bpm.The patient's post-shock rhythm of each shock was sinus bradycardia at 50 bpm.The patient was in sinus rhythm at 60 bpm with nsvt at 04:03:34.The patient received the third inappropriate shock at 04:04:50.The patient's rhythm at the time of the shock was sinus rhythm at 60 bpm with nsvt.The patient's post-shock rhythm was sinus rhythm at 65 bpm with nsvt.The patient's rhythm transitioned to vt at 180 bpm at 04:06:28.The lifevest detected the vt arrhythmia, but the rhythm self-converted to sinus rhythm at 60 bpm with nsvt, preventing the lifevest from delivering a shock.The patient's rhythm transitioned to vt at 240 bpm at 04:10:38.The patient received the thirtieth and thirty-first appropriate shocks at 04:11:09 and 04:14:50.The patient's rhythm at the time of each shock was vt at 240 bpm.The patient's post-shock rhythms were sinus bradycardia at 50 bpm and sinus rhythm at 60 bpm respectively.The device was shutdown at 11:05:20 on (b)(6) 2021.

Manufacturer Narrative

Device evaluation of the monitor and electrode belt has been completed.The evaluation included review of downloaded software flag files on the day of the event and incoming functional testing.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the ecg electrodes, followed by a 5hz simulated treatable arrhythmia signal which verified proper performance of the detection algorithm.During the transition to the 5hz signal, the device was confirmed to properly enter into a treatment sequence which includes a verification of the tactile vibration alarm, audio messaging, and siren alarms, as well as a test of the pulse delivery circuitry.The pulse delivery circuitry test verified proper charging of the high voltage capacitors and proper delivery of five full energy 150j biphasic pulses.The functional testing confirmed proper response button functionality, ecg acquisition, detection algorithm performance, and pulse delivery functionality.There is no indication of a product malfunction.Device manufacture date monitor 09/01/2015, belt 12/20/2018.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238 3495
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238 3495
• Manufacturer Contact: matthew saich ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 13426595
• MDR Text Key: 284906956
• Report Number: 3008642652-2022-01218
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005005
• UDI-Public: 00855778005005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Device Catalogue Number: 10A0988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death