FDA Adverse Event Malfunction Summary report: N

VITALITY 2

MDR report key: 2911396 · Received January 11, 2013

Report

Report Number: 2124215-2012-16153
Event Type: Malfunction
Date Received: January 11, 2013
Date of Event: November 27, 2012
Report Date: January 9, 2013
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

ALL AVAILABLE INFORMATION INDICATES THE DEVICE REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED END OF LIFE (EOL) AFTER EXPERIENCING ONE CHARGE TIME GREATER THAN 30 SECONDS. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE; THE RESULTS INDICATED THAT THE MONITORING VOLTAGE WAS NORMAL. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, EOL WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES [, AND THE ERI TO EOL TIME PERIOD WAS SHORTENED,] DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED ELECTIVE REPLACEMENT INDICATOR (ERI) SOONER THAN EXPECTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ADVISED THIS DEVICE COULD PREMATURELY DEPLETE BASED ON MONITORING VOLTAGE AND LONGER CHARGE TIMES. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

Description of Event or Problem · 1

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
18370	VITALITY 2	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	T177

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR			0181\| 6936\| T177\| MISMATCH