TELIGEN
Report
- Report Number
- 2124215-2012-15210
- Event Type
- Malfunction
- Date Received
- January 11, 2013
- Date of Event
- November 5, 2012
- Report Date
- April 5, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Removal / Correction Number
- Z-0026-2014
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. ATTEMPTS TO INTERROGATE THE DEVICE WERE UNSUCCESSFUL AS THE DEVICE HAD REVERTED TO STORAGE MODE PRIOR TO EXPLANT ((B)(6) 2013). REVIEW OF THE DEVICE MEMORY CONFIRMED THREE LOW VOLTAGE BATTERY FAULTS (FAULT CODE 1003) HAD BEEN RECORDED. EXTERNAL VISUAL INSPECTION OF THE DEVICE NOTED NO ANOMALIES. THE DEVICE DID NOT PASS AUTOMATED PACING AND SHOCK TESTS DUE TO THE DEPLETED CELL (1.944 VOLTS). 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.
THE INVESTIGATION OF THIS EVENT IS ON-GOING AS A REQUEST HAS BEEN MADE TO THE LOCAL REPRESENTATIVE FOR ADDITIONAL INFORMATION.
(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.
THE DEVICE IS CURRENTLY UNDERGOING LABORATORY TESTING.
THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
THE LOCAL REPRESENTATIVE WAS CONTACTED TO DISCUSS THE REVIEW OF STORED DATA. THE REVIEW CONFIRMED THAT A LOW VOLTAGE FAULT WAS DECLARED IN MID-SEPTEMBER 2012 DUE TO THREE DAILY VOLTAGES BELOW THE THRESHOLD OF 3.025 VOLTS. THERE NO OTHER FAULTS OR RESETS STORED WITHIN DEVICE MEMORY. THE VOLTAGE IS CURRENTLY 2.943 VOLTS AND THERAPY DELIVERY IS UNAFFECTED. ANALYSIS OF THE DATA CONFIRMED THAT THE BATTERY STATUS INDICATORS ARE NOT REFLECTING THE DEPLETION CONDITION AND ARE INACCURATE. 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 312UA OVER THE EXPECTED NOMINAL VALUE OF 13UA. TO DATE, THE BEHAVIOR APPEARS CONSISTENT OVER TIME BUT MAY CHANGE UNPREDICTABLY. AT THIS POINT, THE BATTERY DOES HAVE A SIGNIFICANT RESERVE CAPACITY. IF THE FAULT CURRENT WERE TO INCREASE SEVERAL TIMES MORE THAN THE MAXIMUM CALCULATED CURRENT, THEN THE DEVICE MAY LOSE THE ABILITY TO DELIVER THERAPY WITHIN A REPLACEMENT WINDOW OF 1 WEEK. TECHNICAL SERVICES RECOMMENDED THAT THE DEVICE SHOULD BE REPLACED. THE PHYSICIAN HAS ORDERED A REMOTE MONITORING SYSTEM FOR THE PATIENT. THE PATIENT WILL BE SCHEDULED FOR WEEKLY REMOTE FOLLOW-UPS. IT APPEARS THAT THE PATIENT HAS REQUESTED NO INVASIVE INTERVENTION SO THE PHYSICIAN IS DETERMINING WHETHER REMOTE FOLLOW-UPS ARE ADEQUATE AT THIS TIME. TS REMINDED THE LOCAL REPRESENTATIVE THAT THE BATTERY GAUGE IS NOT ACCURATE DUE TO THIS ABERRANT PATHWAY OF LEAKING ENERGY. THE LOCAL REPRESENTATIVE UNDERSTOOD AND KNOWS THAT THERE COULD BE FUTURE FAULTS, OR IF THERAPY IS COMPROMISED, THE DEVICE WILL NOT BE ABLE TO TRANSMIT REMOTELY.
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BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ANOTHER FAULT CODE#1003 (VOLTAGE TOO LOW FOR REMAINING CAPACITY) WAS DISPLAYED. TS RECOMMENDED THAT THE DEVICE SHOULD BE EXPLANTED AND REPLACED. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE COULD NOT BE INTERROGATED AND DISPLAYED A FAULT CODE#1004 (LOW VOLTAGE WARNING). THE PATIENT WAS PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY AND THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED WITHOUT INCIDENT. THE DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT.
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS) TO REPORT THAT THIS DEVICE DISPLAYED A FAULT CODE#1003 (VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY) UPON INTERROGATION. TS DISCUSSED THE ISSUE AND RECOMMENDED DEVICE REPLACEMENT. THE PATIENT REPORTED THAT THE DEVICE WAS GENERATING FAINT BEEPING TONES. SUBSEQUENTLY, THE LOCAL REPRESENTATIVE CONTACTED TS TO REPORT THAT A MEMORY UPLOAD WAS PERFORMED AND WAS ENROUTE TO BOSTON SCIENTIFIC FOR ANALYSIS.
SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PHYSICIAN AND THE PATIENT HAVE DECIDED TO PERFORM WEEKLY DEVICE CHECKS THROUGH THE PATIENT'S MONITORING SYSTEM. THE DEVICE WILL BE REPLACED AT A LATER DATE OR UPON THE PATIENT'S REQUEST. BECAUSE OF THE PATIENT'S AGE, THE PATIENT FEELS THAT CHANGING THE DEVICE AT THIS TIME IS NOT IN HIS BEST INTEREST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 16901 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | 4473| 0185| E110 |