FDA Adverse Event Injury Summary report: N

TELIGEN

MDR report key: 1953551 · Received January 10, 2011

Report

Report Number: 2124215-2010-23946
Event Type: Injury
Date Received: January 10, 2011
Date of Event: December 10, 2010
Report Date: January 27, 2011
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. TO DATE, THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AN AMENDED REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, DETAILED ANALYSIS CONFIRMED THAT THIS DEVICE HAD NOT DELIVERED ANY ATP SCHEMES AND THE ONLY SHOCK DELIVERED WAS INDUCED. THE HEADER WAS SECURE ON THE DEVICE CASE. THE DEVICE PASSED ELECTRICAL TESTING WHICH VERIFIED PACING, SENSING, DEFIBRILLATION, AND RECORDING FUNCTIONS. ANALYSIS HAS CONFIRMED THAT THIS DEVICE PERFORMED NORMALLY THROUGHOUT TESTING, OPERATING AS DESIGNED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR HAD STARTED TO ERODE THROUGH THE SURFACE OF THE PATIENT'S DEVICE POCKET. A POCKET REVISION WAS PERFORMED; AND THE DECISION WAS MADE TO REMOVE AND REPLACE THE DEVICE AS THIS DEVICE WAS INCLUDED IN THE SUBPECTORAL IMPLANT 2009 PRODUCT ADVISORY. THE NEW DEVICE WAS PLACED SUBMUSCULAR. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

THE EXPLANTED DEVICE WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

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	65 YR		Required Intervention	(B)(4)