TELIGEN
Report
- Report Number
- 2124215-2010-24085
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- November 18, 2010
- Report Date
- September 19, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.
THE PROXIMAL CONNECTION WAS UNSCREWED AND RECONNECTED TWICE, AND THE IMPEDANCE WAS STILL OUT OF RANGE. AFTER A THIRD ATTEMPT, THE IMPEDANCE WAS 60 OHMS. THE PRODUCTS REMAINED IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS ANALYZED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. REVIEW OF DEVICE MEMORY CONFIRMED THE DEVICE RECORDED A MULTIPLE OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS. THE DEVICE ALSO RECORDED SEVERAL LEAD FAULTS INDICATING A SHORTED SHOCK LEAD AND UNEXPECTED CHARGE TIME BEHAVIOR. THE DEVICE THEN DECLARED BATTERY A BATTERY STATUS OF END OF LIFE (EOL). AN X-RAY OF THE INTERNAL CIRCUITRY FOUND AN INTERNAL FUSE WAS DAMAGED, CONSISTENT WITH DAMAGE CAUSED BY A SHORTED CONDITION DURING SHOCK DELIVERY. LABORATORY TESTING CONFIRMED THAT PACING THERAPY REMAINED AVAILABLE, BUT SHOCK THERAPY WAS UNAVAILABLE DUE TO THE ABOVE-MENTIONED CIRCUIT DAMAGE. LABORATORY ANALYSIS CONCLUDED THE DEVICE REACHED EOL DUE TO EXTERNAL SHORTING TO THE DEVICE CASE WHICH CAUSED DAMAGE TO THE INTERNAL FUSE. WE BELIEVE THE OPEN/DAMAGED FUSE PREVENTED THE HIGH VOLTAGE CAPACITORS FROM CHARGING WITHIN 45 SECONDS, CAUSING THE DEVICE TO DECLARE EOL. ANALYSIS WAS UNABLE TO CONCLUSIVELY DETERMINE THE CAUSE OF THE HIGH IMPEDANCE MEASUREMENTS RECORDED WHILE IMPLANTED.
A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT GAVE TROUBLESHOOTING RECOMMENDATIONS. THIS REPORT WILL BE UPDATED ONCE ADDITIONAL INFORMATION IS AVAILABLE.
A REPLACEMENT PROCEDURE IS PENDING.
THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
THE DEVICE WAS LATER EXPLANTED AND REPLACED.
FURTHER INFORMATION WAS RECEIVED THAT, UPON INTERROGATION DURING A ROUTINE FOLLOW-UP APPOINTMENT, THE DEVICE INDICATED IT HAD RECORDED SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS AND LESS THAN 20 OHMS. SHOCK IMPEDANCES WERE TESTED IN DIFFERENT CONFIGURATIONS. NO OUT OF RANGE IMPEDANCES WERE MEASURED WHILE IN THE CLINIC.
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, DURING A ROUTINE DEVICE REPLACEMENT PROCEDURE, THIS DEVICE HAD A SHOCK IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
FURTHER INFORMATION WAS RECEIVED THAT THIS DEVICE HAD A INDICATED LOW BATTERY STATUS AND CHARGE TIMEOUT FAULTS. TS RECOMMENDED DEVICE REPLACEMENT.
A REVISION PROCEDURE WAS PERFORMED. THE RELATED LEAD WAS SURGICALLY ABANDONED AND REPLACED. THE DEVICE IMPLANT LOCATION WAS MOVED FROM AN ABDOMINAL TO A LEFT SUBCUTANEOUS POSITION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | F102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |