FDA Adverse Event Death Summary report: N

LIFEVEST WCD 4000 SYSTEM

MDR report key: 4251861 · Received November 5, 2014

Report

Report Number: 3008642652-2014-03610
Event Type: Death
Date Received: November 5, 2014
Date of Event: December 5, 2013
Report Date: November 3, 2014
Manufacturer: ZOLL MANUFACTURING CORPORATION
Product Code: MVK
PMA / PMN Number: P010030
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION OF MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) WAS COMPLETED. THE MONITOR AND ELECTRODE BELT WERE FULLY FUNCTIONAL UPON RECEIPT. THERE IS NO INDICATION OF ANY DEVICE MALFUNCTION. ELECTRODE BELT SN (B)(4) MANUFACTURED 09/2013. MONITOR SN (B)(4) - REUSE. ELECTRODE BELT SN (B)(4) - INITIAL USE OF DEVICE.

Description of Event or Problem · 1

DURING A RETROACTIVE REVIEW OF PAST COMPLAINTS FOR POTENTIAL ADVERSE EVENT, CONDUCTED AS A CAPA IN RESPONSE TO A RECENT FDA INSPECTION, A REPORTABLE ADVERSE EVENT WAS DISCOVERED. A ZOLL TERRITORY MANAGER CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) MALE PT WAS FOUND DEAD IN HIS CAR ON (B)(6) 2013 WHILE WEARING THE LIFEVEST. THE PT HAD REPORTEDLY GONE TO THE EMERGENCY ROOM THE NIGHT BEFORE FOR SHORTNESS OF BREATH BUT WAS NOT ADMITTED. AT 11:47:58 ON (B)(6) 2013, THE PT'S RHYTHM DEGRADED TO VT (160 BPM) WITH CPR ARTIFACT. LIFEVEST DETECTION STOPPED AT 11:52:48. THE ELECTRODE BELT WAS DISCONNECTED AT 12:04:44. THE LIFEVEST PROPERLY DETECTED THE VENTRICULAR ARRHYTHMIA. HOWEVER, CPR ARTIFACT DELAYED A TREATMENT FROM BEING DELIVERED. IT IS UNK WHO PERFORMED CPR. THE PT REPORTEDLY PASSED AWAY AT 12:21 PM ON (B)(6) 2013.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
710095	LIFEVEST WCD 4000 SYSTEM	WEARABLE CARDIOVERTER DEFIBRILLATOR	MVK	ZOLL MANUFACTURING CORPORATION	WCD 4000	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR		Death