TELIGEN
Report
- Report Number
- 2124215-2013-01901
- Event Type
- Injury
- Date Received
- April 9, 2013
- Date of Event
- April 27, 2012
- Report Date
- February 5, 2020
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- PHYSICIAN
Narratives
WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.
THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS. THE RETURNED DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. ALL SEAL PLUGS WERE INTACT, SETSCREWS MOVED FREELY, AND SEAL RING MARKS INDICATED THE TERMINAL PIN WAS FULLY INSERTED INTO THE LEAD BARREL. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED NOISE AND IMPEDANCE ISSUES.
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A DEVICE REPLACEMENT PROCEDURE WAS PERFORMED. WHEN THIS CHRONIC RIGHT VENTRICULAR LEAD WAS RECONNECTED TO THE REPLACEMENT DEVICE, LEAD EVALUATION REVEALED STABLE MEASUREMENTS, HOWEVER SHOCK IMPEDANCE MEASUREMENTS HAD INCREASED FROM 69 OHMS TO GREATER THAN 125 OHMS. THIS LEAD WAS DISCONNECTED AND THE CONNECTOR PIN OF THE PROXIMAL AND DISTAL COIL WERE CLEANED AND REINSERTED TO ASSURE THERE WAS NOT A CONNECTION ISSUE. IN ADDITION BETADINE WAS INJECTED ON THE POCKET SITE. SIMILAR MEASUREMENTS WERE OBTAINED, HOWEVER THE FINAL MEASUREMENT WAS 69 OHMS. A DECISION WAS MADE TO LEAD THIS LEAD IMPLANTED. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED FOR ASSISTANCE. THIS DEVICE AND LEAD REMAINS IMPLANTED AND A SIX MONTH FOLLOW UP VISIT HAS BEEN SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. APPROXIMATELY NINE MONTHS LATER, FOLLOW UP REVEALED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. IN ADDITION, NOISE WAS NOTED ON THE SHOCK ELECTROGRAM. A REVISION IS INTENDED IN THE FUTURE. THE PATIENT IS MONITORED REMOTELY.
AN INTERNAL TECHNICAL SERVICE CONSULTANT REVIEWED THE DATA. IT WAS THOUGHT THERE MAY BE A LESS THAN OPTIMAL CONNECTION AS THERE WAS NOISE ON THE SHOCK CHANNEL UNRELATED TO MYOPOTENTIALS. REMOTE MONITORING REVEALED ONE NON-SUSTAINED EPISODE HAD BEEN STORED AND NO ARTIFACTS WERE NOTED ON THE SHOCK LEAD OR RV LEAD. A HIGH RESOLUTION X-RAY AND FURTHER LEAD INTEGRITY TESTING TO RULE OUT A POSSIBLE FRACTURE WAS FURTHER RECOMMENDED.
ADDITIONAL INFORMATION WAS RECEIVED. REMOTE MONITORING REVEALED A FURTHER OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THIS INFORMATION WAS PROVIDED TO THE PHYSICIAN.
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A DEVICE REPLACEMENT PROCEDURE WAS PERFORMED. WHEN THIS CHRONIC RIGHT VENTRICULAR LEAD WAS RECONNECTED TO THE REPLACEMENT DEVICE, LEAD EVALUATION REVEALED STABLE MEASUREMENTS, HOWEVER SHOCK IMPEDANCE MEASUREMENTS HAD INCREASED FROM 69 OHMS TO GREATER THAN 125 OHMS. THIS LEAD WAS DISCONNECTED AND THE CONNECTOR PIN OF THE PROXIMAL AND DISTAL COIL WERE CLEANED AND REINSERTED TO ASSURE THERE WAS NOT A CONNECTION ISSUE. IN ADDITION BETADINE WAS INJECTED ON THE POCKET SITE. SIMILAR MEASUREMENTS WERE OBTAINED, HOWEVER THE FINAL MEASUREMENT WAS 69 OHMS. A DECISION WAS MADE TO LEAD THIS LEAD IMPLANTED. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED FOR ASSISTANCE. THIS LEAD REMAINS IMPLANTED AND A SIX MONTH FOLLOW UP VISIT HAS BEEN SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. APPROXIMATELY NINE MONTHS LATER, FOLLOW UP REVEALED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. IN ADDITION, NOISE WAS NOTED ON THE SHOCK ELECTROGRAM. A REVISION IS INTENDED IN THE FUTURE. THE PATIENT IS MONITORED REMOTELY. AN INTERNAL TECHNICAL SERVICE CONSULTANT REVIEWED THE DATA. IT WAS THOUGHT THERE MAY BE A LESS THAN OPTIMAL CONNECTION AS THERE WAS NOISE ON THE SHOCK CHANNEL UNRELATED TO MYOPOTENTIALS. REMOTE MONITORING REVEALED ONE NON-SUSTAINED EPISODE HAD BEEN STORED AND NO ARTIFACTS WERE NOTED ON THE SHOCK LEAD OR RV LEAD. A HIGH RESOLUTION X-RAY AND FURTHER LEAD INTEGRITY TESTING TO RULE OUT A POSSIBLE FRACTURE WAS FURTHER RECOMMENDED. ADDITIONAL INFORMATION WAS RECEIVED. REMOTE MONITORING REVEALED A FURTHER OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THIS INFORMATION HAS BEEN PROVIDED TO THE PHYSICIAN. ADDITIONAL INFORMATION WAS RECEIVED THAT A SYSTEM REVISION WAS PERFORMED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND THE RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A DEVICE REPLACEMENT PROCEDURE WAS PERFORMED. WHEN THIS CHRONIC RIGHT VENTRICULAR LEAD WAS RECONNECTED TO THE REPLACEMENT DEVICE, LEAD EVALUATION REVEALED STABLE MEASUREMENTS, HOWEVER SHOCK IMPEDANCE MEASUREMENTS HAD INCREASED FROM 69 OHMS TO GREATER THAN 125 OHMS. THIS LEAD WAS DISCONNECTED AND THE CONNECTOR PIN OF THE PROXIMAL AND DISTAL COIL WERE CLEANED AND REINSERTED TO ASSURE THERE WAS NOT A CONNECTION ISSUE. IN ADDITION BETADINE WAS INJECTED ON THE POCKET SITE. SIMILAR MEASUREMENTS WERE OBTAINED, HOWEVER THE FINAL MEASUREMENT WAS 69 OHMS. A DECISION WAS MADE TO LEAVE THIS LEAD IMPLANTED. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED FOR ASSISTANCE. THIS LEAD REMAINS IMPLANTED AND A SIX MONTH FOLLOW UP VISIT HAS BEEN SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. APPROXIMATELY NINE MONTHS LATER, FOLLOW UP REVEALED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. IN ADDITION, NOISE WAS NOTED ON THE SHOCK ELECTROGRAM. A REVISION IS INTENDED IN THE FUTURE. THE PATIENT IS MONITORED REMOTELY. AN INTERNAL TECHNICAL SERVICE CONSULTANT REVIEWED THE DATA. IT WAS THOUGHT THERE MAY BE A LESS THAN OPTIMAL CONNECTION AS THERE WAS NOISE ON THE SHOCK CHANNEL UNRELATED TO MYOPOTENTIALS. REMOTE MONITORING REVEALED ONE NON-SUSTAINED EPISODE HAD BEEN STORED AND NO ARTIFACTS WERE NOTED ON THE SHOCK LEAD OR RV LEAD. A HIGH RESOLUTION X-RAY AND FURTHER LEAD INTEGRITY TESTING TO RULE OUT A POSSIBLE FRACTURE WAS FURTHER RECOMMENDED. ADDITIONAL INFORMATION WAS RECEIVED. REMOTE MONITORING REVEALED A FURTHER OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THIS INFORMATION HAS BEEN PROVIDED TO THE PHYSICIAN. ADDITIONAL INFORMATION WAS RECEIVED THAT A SYSTEM REVISION WAS PERFORMED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND THE RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 145180 | TELIGEN | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | LWP | BOSTON SCIENTIFIC CORPORATION | F102 | 115175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Hospitalization| L| R | 1852| 1793| 0125| F102 |