FDA Adverse Event Malfunction Summary report: N

COGNIS

MDR report key: 3800967 · Received May 8, 2014

Report

Report Number: 2124215-2014-10443
Event Type: Malfunction
Date Received: May 8, 2014
Date of Event: July 23, 2009
Report Date: March 27, 2014
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWP
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: HEALTH PROFESSIONAL

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.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT ATRIAL (RA) LEAD IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A LOW INTRINSIC AMPLITUDE, AS WELL AS A PAUSE IN ATRIAL PACING FOR 3.2 SECONDS. THE ATRIAL IMPEDANCE WAS NOTED TO BE NORMAL AT 521 OHMS. TECHNICAL SERVICES (TS) DISCUSSED THAT THERE WAS NOISE ON THE RV CHANNEL, AND THAT THE PAUSE IN ATRIAL PACING MAY HAVE BEEN DUE TO OVERSENSING OF THE RV NOISE AND RESETTING OF THE TIMING. TS RECOMMENDED TROUBLESHOOTING OPTIONS. APPROXIMATELY TWO AND A HALF YEARS LATER THE REMOTE HOME MONITORING SYSTEM ISSUED A CHECK ATRIAL LEAD ALERT FOR AN UNKNOWN REASON. TWO YEARS LATER ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE RIGHT ATRIAL (RA) LEAD CONTINUED TO EXHIBIT LOW P WAVE MEASUREMENTS OF 0.3 TO 0.4 MILLIVOLTS. FURTHER, AN INCREASE IN THRESHOLD VALUE WAS OBSERVED. THE IMPEDANCE MEASUREMENT WAS NOTED TO BE STABLE AND THERE WERE NO OCCURRENCES OF UNDERSENSING. NO FURTHER ACTION PLANNED AT THIS TIME. THE PATIENT WILL CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
277188	COGNIS	IMPLANTABLE CHF PULSE GENERATOR	LWP	GUIDANT CRM CLONMEL IRELAND	N118

Patients

Seq	Age	Sex	Outcome	Treatment
1	86 YR			N118\| 0157\| 4087\| H175\| 4513