TELIGEN

Report

Report Number: 2124215-2014-10979
Event Type: Malfunction
Date Received: July 1, 2014
Date of Event: January 31, 2014
Report Date: May 14, 2014
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWP
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). 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 RECEIVED INFORMATION THAT THIS SYSTEM HAD DISPLAYED MULTIPLE EVENS WITH NOISE ON THE RATE SENSE CHANNEL WHICH WAS BEING OVERSENSED. THERE WAS NOT NOISE OBSERVED DURING MANIPULATION OF THE DEVICE HEADER; HOWEVER, NOISE WAS RE-CREATED DURING ARM MOVEMENTS. IMPEDANCE MEASUREMENTS HAVE SLIGHTLY DECREASED SINCE IMPLANT AND THRESHOLD MEASUREMENTS HAVE SLIGHTLY INCREASED. IT WAS NOTED THAT THE DEVICE IS LOOSE IN THE POCKET AS WELL. A REVISION PROCEDURE WAS PERFORMED AND THIS DEVICE WAS EXPLANTED AND REPLACED WITHOUT FURTHER INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
383557	TELIGEN	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWP	GUIDANT CRM CLONMEL IRELAND	E102

Patients

Seq	Age	Sex	Outcome	Treatment
1	84 YR			E102\| 0185