TELIGEN

MDR report key: 1851316 · Received October 4, 2010

Report

Report Number: 2124215-2010-13901
Event Type: Injury
Date Received: October 4, 2010
Date of Event: July 6, 2010
Report Date: July 16, 2010
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS RETURNED AND DETAILED ANLAYSIS IS PENDING.

Additional Manufacturer Narrative · 1

A REQUEST WAS MADE FOR PRODUCT RETURN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED DUE TO A POCKET EROSION. THE DEFIBRILLATION AND TRANSVENOUS LEADS REMAIN IN-SERVICE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TELIGEN	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	E110

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR		Required Intervention	0157\| E110\| 4086