FDA Adverse Event Injury Summary report: N

VITALITY 2

MDR report key: 1863638 · Received October 11, 2010

Report

Report Number: 2124215-2010-15667
Event Type: Injury
Date Received: October 11, 2010
Date of Event: August 3, 2010
Report Date: September 10, 2010
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Removal / Correction Number: Z-1047-2007 TO Z-1055-20
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS EXPLANTED. WHEN IT IS RETURNED FOR ANALYSIS, OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FINAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE EXTENDED MID-LIFE ERI CHARGE TIME LIMIT. 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, ERI AND EOL WERE TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE.

Description of Event or Problem · 1

BOSTON SCIENTIFC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED SECONDARY TO PREMATURE BATTERY DEPLETION. THIS DEVICE IS INCLUDED IN THE SHORTENED REPLACEMENT WINDOW ADVISORY (04/05/2007). NO ADVERSE EFFECTS WERE REPORTED. A NEW DEVICE WAS SUCCESSFULLY IMPLANTED.

Description of Event or Problem · 1

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention