TELIGEN
Report
- Report Number
- 2124215-2013-02414
- Event Type
- Malfunction
- Date Received
- April 9, 2013
- Date of Event
- January 27, 2013
- Report Date
- February 22, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
THE AVAILABLE INFORMATION SUGGESTS THAT THIS DEVICE REMAINS IN-SERVICE.
UPON RETURN, THE DEVICE WILL UNDERGO DETAILED ANALYSIS TO DETERMINE ROOT CAUSE.
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. EXTERNAL VISUAL INSPECTION OF THE DEVICE REVEALED NO ANOMALIES. THE DEVICE WAS PUT THROUGH AND PASSED A SERIES OF AUTOMATED DIAGNOSTIC TESTS THAT VERIFIED THE PERFORMANCE OF DEFIBRILLATION, PACING, SENSING, MEMORY AND RECORDING FUNCTIONS OF THE DEVICE. REVIEW OF THE DEVICE MEMORY CONFIRMED THAT FAULT CODE 1003 WAS RECORDED ON (B)(6) 2013. ALTHOUGH THE DEVICE MEMORY DIAGNOSTICS DEMONSTRATED THAT THE DAILY BATTERY VOLTAGE MEASUREMENTS DISPLAYED AN IRREGULAR PATTERN OF DISCHARGE, THE BATTERY VOLTAGE LEVEL AT EXPLANT WAS SUFFICIENT TO ENSURE THERAPY AVAILABILITY/DELIVERY WHILE THE DEVICE WAS IMPLANTED. THE DEVICE CASE WAS THEN OPENED TO FACILITATE ANALYSIS OF THE INTERNAL COMPONENTS. THE BATTERY WAS SEPARATED FROM THE OTHER DEVICE ELECTRONICS AND THE OVERALL CURRENT DRAW OF THE CIRCUITRY WAS MEASURED. A NORMAL CURRENT DRAIN WAS OBSERVED WITHIN THE CIRCUITRY. COLLECTIVELY, THE PATTERN OF IRREGULAR DAILY BATTERY VOLTAGE MEASUREMENTS IN CONJUNCTION WITH NORMAL POWER LEVELS AND DEVICE HYBRID CURRENT DRAW IS CONSISTENT WITH BEHAVIOR OF DEVICES WHERE A LATENT CURRENT LEAKAGE PATH HAS OCCURRED WITHIN THE BATTERY ITSELF, RESULTING IN A PARTIAL DEPLETION OF THE BATTERY.
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS) TO REPORT THAT THIS PATIENT'S MONITORING SYSTEM DETECTED A YELLOW ALERT (VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY). TS DISCUSSED THE ISSUE AND RECOMMENDED THAT THE DEVICE SHOULD BE EXPLANTED AND REPLACED. THE PATIENT WAS SEEN IN-CLINIC FOR A DEVICE CHECK. UPON INTERROGATION, A FAULT CODE#1003 WAS DISPLAYED. TS SUGGESTED THAT A MEMORY UPLOAD SHOULD BE PERFORMED TO DETERMINE THE CURRENT CONDITION OF THE DEVICE'S BATTERY. A MEMORY UPLOAD WAS PERFORMED AND WAS ANALYZED BY BOSTON SCIENTIFIC'S IN-HOUSE ENGINEERING. A LOW VOLTAGE FAULT WAS DECLARED ON (B)(6) 2013, DUE TO 3 DAILY VOLTAGES BEING BELOW THE THRESHOLD OF 3.025 VOLTS. THE VOLTAGE HAS CURRENTLY RECOVERED TO 3.017 VOLTS AND THERAPY DELIVERY IS UNAFFECTED. A LONGEVITY CALCULATION FOR THE DEVICE USING THE MEMORY DUMP DATA SHOWS THAT THE DEVICE COULOMB COUNTER AND POWER LEVELS ARE IN LINE WITH NOMINAL VALUES. THE DEVICE HARDWARE IS NOT DETECTING THE LOSS OF BATTERY ENERGY AND BECAUSE OF THIS THE BATTERY STATUS INDICATORS ARE NOT REFLECTING THE DEPLETION CONDITION AND ARE INACCURATE. THE DEVICE IS MALFUNCTIONING AND SHOULD BE REPLACED PROMPTLY. THE BEHAVIOR APPEARS INCONSISTENT OVER TIME AND THE FAILURE MODE MAY CHANGE UNPREDICTABLY, HOWEVER, AT THIS TIME THE BATTERY DOES HAVE A SIGNIFICANT RESERVE CAPACITY. THE DATA INDICATES THAT THERE IS SUFFICIENT RESERVE FOR THE DEVICE TO MAINTAIN NORMAL THERAPY FUNCTIONS FOR 1 WEEKS' TIME.
SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED.
THE DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 147106 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | 4469| 0184| E110 |