TELIGEN
Report
- Report Number
- 2124215-2012-17055
- Event Type
- Malfunction
- Date Received
- January 14, 2013
- Date of Event
- December 13, 2012
- Report Date
- June 10, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Removal / Correction Number
- Z-0026-2014
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
AT THIS TIME, THE ICD REMAINS IMPLANTED AND IN SERVICE. A DEVICE REPLACEMENT HAS BEEN SCHEDULED FOR THE PATIENT TO OCCUR NEXT MONTH. ONCE THE ICD IS REPLACED, IT WILL BE RETURNED FOR LABORATORY ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ONCE ANY FURTHER INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
(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 PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.
UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. REVIEW OF THE DEVICE MEMORY CONFIRMED A LOW VOLTAGE BATTERY FAULT (FAULT CODE 1003) HAD BEEN RECORDED. EXTERNAL VISUAL INSPECTION OF THE DEVICE NOTED FLUID IN THE PORTS BUT NO OTHER ANOMALIES WERE FOUND. INITIAL AUTOMATED TESTING VERIFIED BASIC SENSING, PACING AND SHOCKING FUNCTIONS OF THE DEVICE. 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.
A BOSTON SCIENTIFIC ENGINEER REVIEWED THE DATA AND DISCUSSED THAT THE BATTERY IS SHOWING A HIGH CURRENT DRAIN. CURRENTLY, THE BATTERY HAS LIMITED RESERVE CAPACITY AND THE DATA INDICATES THAT THE DEVICE'S ABILITY TO DELIVER THERAPY MAY BECOME COMPROMISED IN A MATTER OF DAYS. THE DEVICE SHOULD BE IMMEDIATELY REPLACED. THIS INFORMATION WAS PROVIDED TO THE FIELD REPRESENTATIVE TO COMMUNICATE WITH TO THE PHYSICIAN. AT THIS TIME THE DEVICE REMAINS IMPLANTED. ONCE ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.
THE DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
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BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A FAULT AND DISPLAYED THE MESSAGE THAT THE BATTERY VOLTAGE WAS TOO LOW FOR PROJECTED REMAINING CAPACITY. THE PATIENT HAD THE ICD INTERROGATED WITH THE REMOTE MONITORING SYSTEM AND THE INFORMATION WAS SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR TECHNICAL ASSISTANCE. A TS CONSULTANT DISCUSSED THAT THIS FAULT INDICATES THAT THE DEVICE'S BATTERY MAY BE DEPLETING FASTER THAN EXPECTED AND REPLACEMENT OF THE DEVICE SHOULD BE CONSIDERED AS SOON AS POSSIBLE. THE PHYSICIAN REVIEWED THE INFORMATION WITH THE PHYSICIAN AND THE PATIENT DID NOT WANT TO HAVE THE DEVICE REPLACED UNTIL (B)(6) 2013 AND ACCEPTED THE RISKS THAT COULD OCCUR AS A RESULT. A MEMORY DOWNLOAD WILL ALSO BE PERFORMED AND SUBMITTED FOR FURTHER ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
ADDITIONAL INFORMATION WAS REPORTED THAT THE PATIENT WITH THIS ICD LIVES IN A REMOTE LOCATION AND REFUSES TO HAVE THE ICD REPLACED BEFORE APRIL. THE PATIENT IS CURRENTLY BEING FOLLOWED ON A REMOTE MONITORING SYSTEM. THE CLINIC HAS ALSO INFORMED THE FIELD REPRESENTATIVE THAT THEY WILL CALL IF THE PATIENT IS SCHEDULED FOR A IN-CLINIC FOLLOW UP SO THAT A MEMORY DOWNLOAD CAN BE PERFORMED AND SENT IN FOR ENGINEERING ANALYSIS.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS SEEN AGAIN AT THE CLINIC. A MEMORY DOWNLOAD WAS PERFORMED AND SENT IN TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 20621 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | E110| 1688T| MISMATCH |