FDA Adverse Event Malfunction Summary report: N

CONTAK RENEWAL

MDR report key: 2910707 · Received January 11, 2013

Report

Report Number: 2124215-2012-15611
Event Type: Malfunction
Date Received: January 11, 2013
Date of Event: November 16, 2012
Report Date: May 27, 2015
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWP
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

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. 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 THE RIGHT VENTRICULAR (RV) LEAD THRESHOLD MEASUREMENTS HAVE INCREASED GRADUALLY. NO NOISE OR OUT OR RANGE IMPEDANCE MEASUREMENTS HAVE BEEN OBSERVED. AN X-RAY WAS PERFORMED AND REVEALED AN UNDERINSERTION OF THE RV LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

THIS DEVICE WAS SUBSEQUENTLY EXPLANTED AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
16481	CONTAK RENEWAL	IMPLANTABLE CHF GENERATOR	LWP	GUIDANT CRM CLONMEL IRELAND	H195

Patients

Seq	Age	Sex	Outcome	Treatment
1