FDA Adverse Event Injury Summary report: N

VITALITY 2

MDR report key: 2913726 · Received January 14, 2013

Report

Report Number: 2124215-2013-00132
Event Type: Injury
Date Received: January 14, 2013
Date of Event: November 21, 2012
Report Date: January 3, 2013
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Description of Event or Problem · 1

THE SALES REPRESENTATIVE NOTED THAT THE DEVICE WAS THOUGHT TO HAVE BEEN DISCARDED BY HOSPITAL STAFF AND WOULD NOT BE RETURNED FOR RELIABILITY ANALYSIS.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE HAD DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) AND APPROXIMATELY ONE MONTH LATER, END OF LIFE (EOL). A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE DEVICE WAS EMITTING A CONTINUOUS BEEPING TONE. UPON DEVICE INTERROGATION, THE BATTERY DISPLAYED A MONITORING VOLTAGE OF 2.20 V WITH A CHARGE TIME MEASUREMENT OF 45.1 SECONDS. AS A RESULT OF THE EXTENDED CHARGE TIME MEASUREMENT, A FAULT CODE WAS ALSO OBSERVED, ALONG WITH THE EOL DECLARATION. THE PATIENT WITH THIS DEVICE WAS NOT PACER DEPENDENT, HOWEVER, TECHNICAL SERVICES WAS CONSULTED AND RECOMMENDED DEVICE REPLACEMENT. NO ALLEGATIONS AGAINST THE DEVICE'S FUNCTIONALITY WERE PRESENTED. A REVISION PROCEDURE WAS PERFORMED AND THIS DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
19691	VITALITY 2	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	T165

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR		Hospitalization\| L\| R	0184\| 4076\| T165