TELIGEN

Report

Report Number: 2124215-2013-06565
Event Type: Injury
Date Received: July 8, 2013
Date of Event: April 17, 2013
Report Date: May 24, 2013
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

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. 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 THERE WERE HIGH PACING IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD. AS A RESULT, THE POCKET WAS OPENED AND THE LEAD WAS TESTED THROUGH THE PACING SYSTEM ANALYZER (PSA). ALL MEASUREMENTS WERE APPROPRIATE. THEREFORE, THE DECISION WAS MADE TO EXPLANT THE DEVICE AND IMPLANT A NEW COMPETITOR DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

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Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
309876	TELIGEN	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	F102

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| L\| R