FDA Adverse Event Injury Summary report: N

VITALITY 2

MDR report key: 2052160 · Received April 12, 2011

Report

Report Number: 2124215-2011-03613
Event Type: Injury
Date Received: April 12, 2011
Date of Event: January 31, 2011
Report Date: June 7, 2011
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE EXPLANTED DEVICE WAS NOT RETURNED TO BOSTON SCIENTIFIC, THEREFORE, THE CLINICAL OBSERVATIONS COULD NOT BE CONFIRMED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

Additional Manufacturer Narrative · 1

TO DATE, THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT, THE DEVICE WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS AT MIDDLE OF LIFE ON (B)(6) 2010. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2011 STATING THAT THE DEVICE WAS BEEPING. UPON INTERROGATION OF THE DEVICE, IT WAS DISCOVERED THAT THE DEVICE HAD DECLARED THE ELECTIVE REPLACEMENT INDICATOR ON (B)(6) 2011 AND END OF LIFE ON (B)(6) 2011. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS REMOVED, REPLACED, AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

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			Other\| R