VITALITY 2

Report

Report Number: 2124215-2014-11983
Event Type: Injury
Date Received: July 3, 2014
Date of Event: May 10, 2014
Report Date: July 23, 2014
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS KEPT BY THE HOSPITAL. AS THE LEAD WILL NOT BE RETURNED FOR ANALYSIS, THE CLINICAL OBSERVATIONS CANNOT BE CONFIRMED.

Description of Event or Problem · 1

SUBSEQUENT INFORMATION WAS RECEIVED WHICH INDICATES THAT THIS ICD WAS ALREADY EXPLANTED. ADDITIONAL INFORMATION WAS OBTAINED FROM THE FIELD REPRESENTATIVE WHO CONFIRMED THAT THE DEVICE WAS KEPT BY THE HOSPITAL AND WILL NOT BE AVAILABLE FOR RETURN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) RAPIDLY. IT IS NOTED THAT THE DEVICE EXHIBITED NORMAL OUTPUTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED REPLACEMENT PERIOD AND NUMBER OF THERAPIES OF REACHING ERI. ADDITIONAL INFORMATION OBTAINED FROM THE FIELD REPRESENTATIVE THAT THE PATIENT IS SCHEDULED FOR REVISION WITHIN NEXT MONTH AND WILL RETURN THE DEVICE. AT THIS TIME, THE ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
389655	VITALITY 2	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	T165

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR		Hospitalization\| L\| R	T165\| 0148\| 1861\| 1762\| 4037\| 0125