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

Model Number WCD 4000

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problem Death (1802)

Event Date 02/06/2012

Event Type  Death  

Event Description

During a retrospective review of past complaints for potential adverse events, conducted as a capa in response to a recent fda inspection, a reportable adverse event was discovered.The wife of a (b)(6) pt contacted zoll to report his death.The pt passed away on (b)(6) 2012 at 4:00am.The pt was not wearing the device at the time of death.While monitoring the pt's rhythm, no sustained ventricular tachyarrhythmias were detected.Subsequent monitoring of the pt's rhythm was not possible due to device deactivation.On (b)(6) 2012, the pt's wife called in stating that the pt went into heart failure while wearing the lifevest and it did not alarm.The pt's wife stated that the pt was having a heart attack and her son-in-law helped him and they dialed 911.The paramedics came and checked all of the leads and couldn't understand why the lifevest did not work.The paramedics transported the pt to the hospital and he bolted upright and his heart rate went up to 197.The hospital took the lifevest off at that point.The pt's wife said "she just knows it didn't work".The treatment analysis from (b)(6) 2012 showed that bradycardia was detected from 05:08:01 to 11:44:38.Then an arrhythmia was declared at 14:48:31.The ecg recording showed ventricular bigeminy transitions to a 12-second non-sustaining ventricular tachycardia.The rhythm went back to bradycardia.Then another arrhythmia was detected at 03:23:53 on (b)(6) 2012.The ecg recording showed dual-lead signal artifact with suspected bradycardia and ventricular bigeminy.The device was shutdown at 12:24:08.

Manufacturer Narrative

Device eval summary: device eval of monitor sn (b)(4) and electrode belt sn (b)(4) was completed.The monitor and electrode belt were both fully functional upon receipt.Monitor sn (b)(4) - reused.Electrode belt sn (b)(4), manufacture date: 01/2011 - reuse.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; pittsburgh PA 15238 349
• Manufacturer Contact: nina rudolph ; 121 gamma dr; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 4262519
• MDR Text Key: 5108938
• Report Number: 3008642652-2014-04040
• Device Sequence Number: 1
• Product Code: MVK
• Combination Product (y/n): N
• PMA/PMN Number: P010030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Type of Report: Initial
• Report Date: 11/12/2014

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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/10/2012
• Initial Date Manufacturer Received: 10/31/2014
• Initial Date FDA Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2009
• 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
• Patient Age: 85 YR