TELIGEN
Report
- Report Number
- 2124215-2013-01824
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- January 16, 2013
- Report Date
- April 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
- PHYSICIAN
Narratives
THE INVESTIGATION OF THIS EVENT IS ONGOING. AWAITING RESULTS OF THE DEVICE FOLLOW-UP AND RETURN OF A MEMORY UPLOAD FOR ANALYSIS. TO DATE, A MEMORY UPLOAD HAS NOT BEEN RETURNED. UPON RECEIPT, THE DEVICE WILL UNDERGO DETAILED LABORATORY TESTING TO DETERMINE ROOT CAUSE.
(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 AVAILABLE INFORMATION SUGGESTS THAT THIS DEVICE REMAINS IN-SERVICE. THE INVESTIGATION OF THIS EVENT IS ON-GOING AS A REQUEST HAS BEEN MADE TO THE LOCAL REPRESENTATIVE FOR ADDITIONAL INFORMATION.
UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. REVIEW OF THE DEVICE MEMORY CONFIRMED THAT A LOW VOLTAGE BATTERY FAULT (FAULT CODE 1003) HAD BEEN RECORDED. EXTERNAL VISUAL INSPECTION OF THE DEVICE NOTED TOOL MARKS ON THE FRONT OF THE DEVICE CASING JUST BELOW THE HEADER. 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.
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE WAS INFORMED BY THE PHYSICIAN THAT THIS DEVICE DISPLAYED A FAULT CODE#1003 (VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY). THE LOCAL REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS) AND THE ISSUE WAS DISCUSSED. TS SUGGESTED THAT A MEMORY UPLOAD COULD BE PERFORMED TO UNDERSTAND THE CONDITION OF THE DEPLETING BATTERY. ADDITIONALLY, THE LOCAL REPRESENTATIVE WAS INFORMED THAT THE DEVICE SHOULD BE EXPLANTED AND REPLACED.
BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE LOCAL REPRESENTATIVE THAT THIS PATIENT HAS BEEN SCHEDULED FOR A DEVICE FOLLOW-UP AT THE CLINIC IN (B)(6) 2013. THE PHYSICIAN IS AWARE OF THE RECOMMENDATION FOR DEVICE REPLACEMENT. THE LOCAL REPRESENTATIVE WILL PERFORM A MEMORY UPLOAD AT THE TIME OF THE DEVICE FOLLOW-UP IN (B)(6). SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE LOCAL REPRESENTATIVE THAT THE DEVICE WAS INTERROGATED AND ANOTHER FAULT CODE#1003 (VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY) WAS DISPLAYED. TS EMPHASIZED THAT THE DEVICE SHOULD BE EXPLANTED AND REPLACED. THE PATIENT WAS PRESENTED BACK TO THE EP LABORATORY. THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED. THE DEVICE IS ENROUTE TO BOSTON SCIENTIFIC FOR LABORATORY TESTING.
THE DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143135 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWP | GUIDANT CRM CLONMEL IRELAND | E110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | 4016| 0154| 1861| E110| T165 |