TELIGEN
Report
- Report Number
- 2124215-2022-04184
- Event Type
- Injury
- Date Received
- February 9, 2022
- Date of Event
- December 6, 2021
- Report Date
- May 21, 2022
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWP
- PMA / PMN Number
- P960040/S155
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 003
Narratives
THE RETURNED DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY. VISUAL EXAMINATION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAGE 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 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 CLINICAL OBSERVATIONS.
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
IT WAS REPORTED THAT THIS DEVICE WAS EMITTING TONES AND ELECTIVE REPLACEMENT INDICATOR (ERI) WAS TRIGGERED. ADDITIONALLY, AN EPISODE OF NOISE AND OVERSENSING WAS IDENTIFIED. THE CALLER WAS INQUIRING ABOUT DEVICE LONGEVITY AS IT WAS OBSERVED TO BE TEN MONTHS TWO DAYS PRIOR AFTER INCREASING THE RIGHT VENTRICULAR (RV) OUTPUT. THE CALLER STATED THERE WAS NO RV PACING AND INQUIRED HOW THE DEVICE COULD REACH ERI IF THERE WAS NO PACING THERAPY. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DOCUMENTED AND DISCUSSED THE REPORTED CLINICAL OBSERVATIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. IT WAS REPORTED THAT THIS DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS DEVICE WAS EMITTING TONES AND ELECTIVE REPLACEMENT INDICATOR (ERI) WAS TRIGGERED. ADDITIONALLY, AN EPISODE OF NOISE AND OVERSENSING WAS IDENTIFIED. THE CALLER WAS INQUIRING ABOUT DEVICE LONGEVITY AS IT WAS OBSERVED TO BE TEN MONTHS TWO DAYS PRIOR AFTER INCREASING THE RIGHT VENTRICULAR (RV) OUTPUT. THE CALLER STATED THERE WAS NO RV PACING AND INQUIRED HOW THE DEVICE COULD REACH ERI IF THERE WAS NO PACING THERAPY. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DOCUMENTED AND DISCUSSED THE REPORTED CLINICAL OBSERVATIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. IT WAS REPORTED THAT THIS DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS DEVICE WAS EMITTING TONES AND ELECTIVE REPLACEMENT INDICATOR (ERI) WAS TRIGGERED. ADDITIONALLY, AN EPISODE OF NOISE AND OVERSENSING WAS IDENTIFIED. THE CALLER WAS INQUIRING ABOUT DEVICE LONGEVITY AS IT WAS OBSERVED TO BE TEN MONTHS TWO DAYS PRIOR AFTER INCREASING THE RIGHT VENTRICULAR (RV) OUTPUT. THE CALLER STATED THERE WAS NO RV PACING AND INQUIRED HOW THE DEVICE COULD REACH ERI IF THERE WAS NO PACING THERAPY. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DOCUMENTED AND DISCUSSED THE REPORTED CLINICAL OBSERVATIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 895596 | TELIGEN | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | LWP | BOSTON SCIENTIFIC CORPORATION | E102 | 243923 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Male | Required Intervention| H |