TELIGEN

Report

Report Number: 2124215-2013-00104
Event Type: Malfunction
Date Received: January 14, 2013
Date of Event: December 23, 2012
Report Date: February 1, 2013
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWP
Removal / Correction Number: Z-0026-2014
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). BOSTON SCIENTIFIC HAS ISSUED AN ADVISORY COMMUNICATION REGARDING AN OLDER SUBSET OF COGNIS/TELIGEN DEVICES THAT IS MORE SUSCEPTIBLE TO THIS ANOMALY. SPECIFICALLY, THE PERFORMANCE OF A LOW VOLTAGE CAPACITOR MAY BE COMPROMISED OVER TIME, CAUSING AN INCREASED CURRENT DRAIN THAT CAN LEAD TO PREMATURE BATTERY DEPLETION. THIS PARTICULAR DEVICE WAS INCLUDED IN THE ADVISORY POPULATION.

Additional Manufacturer Narrative · 1

THE DEVICE IS CURRENTLY UNDERGOING DETAILED LABORATORY TESTING TO DETERMINE ROOT CAUSE.

Additional Manufacturer Narrative · 1

THE AVAILABLE INFORMATION SUGGESTS THAT THIS DEVICE REMAINS INSERVICE AT THIS TIME. A REQUEST FOR DEVICE STATUS HAS BEEN MADE TO THE LOCAL REPRESENTATIVE.

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. REVIEW OF THE DEVICE MEMORY CONFIRMED THREE LOW VOLTAGE BATTERY FAULTS (FAULT CODE 1003) HAD BEEN RECORDED. EXTERNAL VISUAL INSPECTION OF THE DEVICE NOTED BODILY FLUID CONTAMINATION IN THE LEAD BARRELS. AFTER THE TITANIUM CASE WAS OPENED, MICROSCOPIC VISUAL INSPECTION DID NOT REVEAL ANY IRREGULARITIES. THE BATTERY WAS THEN REMOVED, SO THAT AN EXTERNAL POWER SUPPLY COULD BE CONNECTED TO THE DEVICE FOR FURTHER ANALYSIS. A HIGHER THAN NORMAL CURRENT USAGE WAS OBSERVED. ELECTRICAL TESTING ISOLATED THE HIGH CURRENT CONDITION TO TWO COMPROMISED LOW VOLTAGE CAPACITORS THAT ARE CONNECTED TO THE DEVICE'S BATTERY. THIS TYPE OF COMPONENT MALFUNCTION CAN RESULT IN A HIGH CURRENT DRAIN, WHICH OVER TIME CAN RESULT IN PREMATURE BATTERY DEPLETION, AS WAS OBSERVED IN THIS CASE.

Description of Event or Problem · 1

SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LABORATORY. THE CHRONIC DEVICE WAS SUCCESSFULLY EXPLANTED. THE DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS FOR LABORATORY TESTING.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS HEALTH CARE PROFESSIONAL (HCP) CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS) TO REPORT THAT THIS PATIENT'S MONITORING SYSTEM DETECTED A YELLOW ALERT ASSOCIATED WITH A "VOLTAGE IS TOO LOW FOR PROJECTED REMAINING CAPACITY" MESSAGE. ADDITIONALLY, THE DEVICE WAS GENERATING BEEPING TONES. TS DISCUSSED THE ISSUE AND RECOMMENDED THAT THE PATIENT SHOULD BE SCHEDULED FOR DEVICE REPLACEMENT. TS SUGGESTED THAT A SAVE-TO-DISK AND MEMORY UPLOAD COULD BE PERFORMED AND RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. A MEMORY UPLOAD WAS RETURNED AND ANALYSIS CONFIRMED THAT A LOW VOLTAGE FAULT WAS DECLARED IN (B)(6) 2012 DUE TO THREE DAILY VOLTAGES BEING BELOW THE THRESHOLD OF 3.025 VOLTS. THE VOLTAGE IS CURRENTLY 3.022 VOLTS AND THERAPY DELIVERY REMAINS UNAFFECTED. USING THE LAST YEARS' WORTH OF DAILY BATTERY VOLTAGE MEASUREMENT DATA, THE ESTIMATED TRUE DEPTH OF BATTERY DISCHARGE TO OBTAIN AN ESTIMATE OF THE FAULT CURRENT WAS PLOTTED. THE CURRENT APPEARS STEADY WITH AN ADDITIONAL CURRENT DRAIN OF 50UA OVER THE EXPECTED NOMINAL VALUE OF 11UA. TO DATE, THE BEHAVIOR APPEARS CONSISTENT OVER TIME; HOWEVER, THIS MAY CHANGE UNPREDICTABLY. AT THIS POINT, THE BATTERY DOES HAVE A SIGNIFICANT RESERVE CAPACITY. THE DATA INDICATES THAT THERE IS SUFFICIENT RESERVE FOR THE DEVICE MAINTAIN NORMAL THERAPY FUNCTIONS FOR 2 WEEKS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
20488	TELIGEN	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWP	GUIDANT CRM CLONMEL IRELAND	E110

Patients

Seq	Age	Sex	Outcome	Treatment
1	76 YR			E110\| 0185\| 4136