COGNIS

Report

• Report Number: 2124215-2010-16889
• Event Type: Malfunction
• Date Received: October 14, 2010
• Date of Event: August 18, 2010
• Report Date: August 18, 2010
• Manufacturer: GUIDANT CRM CLONMEL IRELAND
• Product Code: NIK
• Product Problem: Yes
• Report Source: Manufacturer report
• Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

TECHNICAL SERVICES DISCUSSED A POSSIBLE INTERMITTENT SETSCREW OR CONNECTION ISSUE, LEAD DISLODGEMENT, OR THAT THE POSITION OF THE LEAD WAS NOT IN CONTACT WITH VIABLE TISSUE. THE PHYSICIAN COULD MONITOR OR PERFORM AN INVASIVE PROCEDURE TO INVESTIGATE THE CONNECTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD REMAINS IN SERVICE. THE FIELD REPRESENTATIVE LATER REPORTED THAT THE PHYSICIAN PLANNED TO CONTINUE TO MONITOR THE LEAD FOR NOW. THE PATIENT EXPERIENCED NO SYMPTOMS DUE TO THE LOSS OF CAPTURE, AND WAS SCHEDULED TO BE SEEN AGAIN THE FOLLOWING MONTH.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND ASSOCIATED CORONARY SINUS LEAD EXHIBITED INTERMITTENT PACING IMPEDANCE MEASUREMENTS THAT WERE >2000 OHMS. LOSS OF CAPTURE WAS ALSO OBSERVED. THIS BEGAN IN AUGUST, AND THE MEASUREMENTS WERE NORMAL ON SOME DAYS AND OUT OF RANGE ON OTHER DAYS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COGNIS	IMPLANTABLE CHF PULSE GENERATOR	NIK	GUIDANT CRM CLONMEL IRELAND	N119

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR			H177| 1488T| 0185| N119| 4542

Terms

Patient problem · 1

• No Consequences Or Impact To Patient

Product problems · 2

• Failure to Capture
• High impedance

Source type · 1

• Company representation

Type of report · 1

• Initial submission