TELIGEN

MDR report key: 1871921 · Received October 16, 2010

Report

Report Number: 2124215-2010-17449
Event Type: Malfunction
Date Received: October 16, 2010
Date of Event: July 14, 2010
Report Date: January 6, 2017
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWP
PMA / PMN Number: P960040
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE REMAINS IN SERVICE.

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. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT 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 CRM RECEIVED INFORMATION THAT DURING IMPLANT THIS LEAD EXHIBITED NOISE AND LOW SHOCK IMPEDANCES. THE LEAD WAS REMOVED AND RESEATED IN THE HEADER WHICH RESOLVED THE ISSUE.

Description of Event or Problem · 1

APPROXIMATELY SIX YEARS LATER THIS DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR