FDA Adverse Event Death Summary report: N

LIFEVEST WCD 4000 SYSTEM

MDR report key: 4250069 · Received November 6, 2014

Report

Report Number: 3008642652-2014-03609
Event Type: Death
Date Received: November 6, 2014
Date of Event: September 20, 2011
Report Date: November 3, 2014
Manufacturer: ZOLL MANUFACTURING CORPORATION
Product Code: MVK
PMA / PMN Number: P010030
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION OF MONITOR SN (B)(4) AND BELT SN (B)(4) WERE COMPLETED. UPON EVALUATION, THE MONITOR AND ELECTRODE BELT WERE FULLY FUNCTIONAL. REVIEW OF THE PT'S ECG AND DOWNLOADED DATA INDICATES THAT PERSISTENT SVT TRIGGERED THE FALSE DETECTIONS RESULTING IN THE INAPPROPRIATE DEFIBRILLATIONS ON (B)(6) 2011. THE PT DIDN'T USE THE RESPONSE BUTTONS DURING THE ENTIRE EVENT. THE POST-SHOCK RHYTHMS WERE SVT AROUND 150-160BPM. THE PT PASSED AWAY (B)(6) 2011. THE CAUSE OF THE PT'S DEATH IS UNK. BELT: 01/2011.

Description of Event or Problem · 1

DURING A RETROACTIVE 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. ON (B)(6) 2011, A (B)(6) FEMALE PT'S DAUGHTER CONTACTED ZOLL AND REPORTED THAT THE PT PASSED AWAY WEARING THE LIFEVEST WHILE IN THE ICU. IT WAS REPORTED THAT LIFEVEST WAS 'GOING OFF BUT NONE OF THE NURSES KNEW HOW TO TURN IT OFF'. REVIEW OF THE EVENT INDICATES THAT THE PT EXPERIENCED EIGHT INAPPROPRIATE DEFIBRILLATIONS ON 09/19/2011. SVT CONTRIBUTED TO THE FALSE DETECTIONS. THE RESPONSES BUTTONS WERE NOT USED DURING THE ENTIRE EVENT. THE PT LATER PASSED AWAY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
715158	LIFEVEST WCD 4000 SYSTEM	WEARABLE CARDIOVERTER DEFIBRILLATOR	MVK	ZOLL MANUFACTURING CORPORATION	WCD 4000	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR		Death