LIFEVEST WCD 4000 SYSTEM

Report

Report Number: 3008642652-2015-01781
Event Type: Death
Date Received: April 7, 2015
Date of Event: March 4, 2015
Report Date: March 31, 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

MONITOR SN (B)(4) AND BELT SN 59078409 HAVE NOT BEEN RETURNED FOR EVALUATION. DEVICE EVALUATION WAS ACCOMPLISHED THROUGH A REVIEW OF THE PATIENT'S DOWNLOADED DATA FILE. REVIEW OF THE DATA DOES NOT INDICATE ANY DEVICE MALFUNCTION RELATED TO THE EVENT. H4: MONITOR (B)(4): 04/2012. ELECTRODE BELT (B)(4): 04/2014.

Description of Event or Problem · 1

A DISTRIBUTOR CONTACTED ZOLL ON (B)(6) 2015 TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2015 AT 5:17 PM. PER THE DISTRIBUTOR, THE PATIENT WAS WITH HIS WIFE ON HIS WAY HOME FROM (B)(6) AND WAS NOT FEELING WELL. HIS WIFE TOOK HIM TO A HOSPITAL IN AL WHERE HE WAS TAKEN TO THE ICU AND LATER DIED. THE PATIENT'S WIFE REPORTED HE WAS TREATED WHILE IN THE ER. AFTER THAT SHE WAS TOLD HE WAS "BRAIN DEAD AND HIS HEART THEN STOPPED." INVESTIGATION INTO THE EVENT REVEALED THAT THE PATIENT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT ON (B)(6) 2015. THE TREATMENT WAS DELIVERED AT 01:28:42 AM. THE RHYTHM AT THE TIME OF THE TREATMENT WAS MOTION ARTIFACT, WHICH CONTRIBUTED TO THE FALSE DETECTION. THE POST SHOCK RHYTHM WAS A SINUS RHYTHM AT 90 BPM WITH MOTION ARTIFACT. A NON-TREATABLE RHYTHM WAS DETECTED AT 01:29:05 AM AND THE DEVICE WAS SHUT DOWN AT 02:04:11 AM. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE ENTIRE EVENT. THE DEVICE WAS NOT ACTIVE AT THE REPORTED TIME OF PASSING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
228264	LIFEVEST WCD 4000 SYSTEM	WEARABLE CARDIOVERTER DEFIBRILLATOR	MVK	ZOLL MANUFACTURING CORPORATION	WCD 4000	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR		Death