ENDOTAK RELIANCE G
Report
- Report Number
- 2124215-2021-33638
- Event Type
- Injury
- Date Received
- November 2, 2021
- Date of Event
- September 30, 2021
- Report Date
- October 24, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- PMA / PMN Number
- P910073/S043
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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: (B)(6) 976893. D121 214726. ESTIMATED SHOCK IMPED > 200 OHMS. TRIAD. >200 OVERALL IN TRIAD RV TO RA >200 RV TO CAN 148 RA TO CAN 159 TREND SHOWS 55 OHMS AT IMPLANT 1.5 YEARS AGO. (B)(6) 2020. 56 OHMS THE DAY AFTER IMPLANT (B)(6) 2020 111 OHMS. LATE OCT 130 OHMS (B)(6) 2021 136 OHMS. APR 112 OHMS. NOTHING ABOVE 140 OHMS N THE DAILIES UNTIL > 200 OHMS. NO SHOCKS HAVE BEEN GIVEN. BEING SEEN AT FERGUSON MD, ROLLINGTON OFFICE. JOHN WEBER IS THE REP FOR THIS ACCOUNT. CALLER FACILITY : NULL NEW ATTACHMENT(S) : NO. ADDITIONAL INFORMATION FROM EVENT RECORD 14282705 & SOURCE SYSTEM ID (B)(6). REP CALLED WITH D121 214726 IN CLINIC AND DISCOVERED SHOCK LEAD IMPEDANCE >200 OHMS PATIENT IS NOT ON NXT. 0185 DUAL COIL LEAD. ONLY AVAILABLE DATA IS FROM TODAY'S CLINIC EVAL. VECTOR BREAKDOWN SHOWED ALL THREE CONTRIBUTING LEGS HAD SIGNIFICANTLY ELEVATED IMPEDANCE MEASUREMENTS. LAST FOLLOW UP WAS ABOUT A YEAR AND A HALF AGO. HISTORICALLY SLI HAD BEEN MID50S. OCTOBER 2020 111/110/120. END OF OCT 2020 115/130/108/113. PT HAS NOT RECEIVED THERAPY. SHOCK LEAD IMPEDANCE TRENDING UPWARD OVER TIME. TS: DISCUSSED LEAD CALCIFICATION BUILD UP ON BOTH COILS, NO SUDDEN JUMPS OBSERVED IN NXT. CONSIDER MAX ENERGY SYNCHRONIZED SHOCK. DISCUSSED DIFFERENCE BETWEEN HIGHER VALUE DAILY MEASUREMENT SLI AND ACTUAL THERAPEUTIC SHOCK-DELIVERED VALUE. IF SLI EXCEEDS 145 OHMS WITH DELIVERED SHOCK, THE ENERGY IS TRUNCATED AND RESULTING SHOCK IS MONOPHASIC. JOHN WEBER IS THE SALES REP FOR THIS ACCOUNT. LOGGED ON BEHALF OF (B)(6). ACCORDING TO ADDITIONAL INFORMATION THE PATIENT PRESENTED TO THE HOSPITAL AFTER AN EPISODE OF VENTRICULAR FIBRILLATION (VF). DURING THE EPISODE, TWO ELECTRIC SHOCKS WERE DELIVERED BY THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. THE FIRST SHOCK DID NOT CONVERT THE RHYTHM, BUT THE SECOND DID. UPON INTERROGATION, A CODE 1005 WAS FOUND FOR A SHOCK INTO AN OPEN CIRCUIT. TS RECOMMENDED DEFIBRILLATION THRESHOLD (DFT) TEST TO ENSURE SHOCK EFFICACY. NO ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE OF THE PATIENT CONDITION. CURRENTLY, THIS LEAD REMAINS IN SERVICE.
IT WAS REPORTED THAT: (B)(6). D121 214726. ESTIMATED SHOCK IMPED > 200 OHMS. TRIAD. >200 OVERALL IN TRIAD RV TO RA >200 RV TO CAN 148 RA TO CAN 159 TREND SHOWS 55 OHMS AT IMPLANT 1.5 YEARS AGO. (B)(6) 2020. 56 OHMS THE DAY AFTER IMPLANT (B)(6) 2020 111 OHMS. LATE OCT 130 OHMS (B)(6) 2021 136 OHMS. (B)(6) 112 OHMS. NOTHING ABOVE 140 OHMS N THE DAILIES UNTIL > 200 OHMS. NO SHOCKS HAVE BEEN GIVEN. BEING SEEN AT (B)(6). (B)(6) IS THE REP FOR THIS ACCOUNT. CALLER FACILITY : NULL NEW ATTACHMENT(S) : NO. ADDITIONAL INFORMATION FROM EVENT RECORD (B)(4) & SOURCE SYSTEM ID (B)(4). REP CALLED WITH D121 214726 IN CLINIC AND DISCOVERED SHOCK LEAD IMPEDANCE >200 OHMS PATIENT IS NOT ON NXT. 0185 DUAL COIL LEAD. ONLY AVAILABLE DATA IS FROM TODAY'S CLINIC EVAL. VECTOR BREAKDOWN SHOWED ALL THREE CONTRIBUTING LEGS HAD SIGNIFICANTLY ELEVATED IMPEDANCE MEASUREMENTS. LAST FOLLOW UP WAS ABOUT A YEAR AND A HALF AGO. HISTORICALLY SLI HAD BEEN MID50S. (B)(6) 2020 111/110/120 END OF (B)(6) 2020 115/130/108/113 PT HAS NOT RECEIVED THERAPY. SHOCK LEAD IMPEDANCE TRENDING UPWARD OVER TIME. TS: DISCUSSED LEAD CALCIFICATION BUILD UP ON BOTH COILS, NO SUDDEN JUMPS OBSERVED IN NXT. CONSIDER MAX ENERGY SYNCHRONIZED SHOCK. DISCUSSED DIFFERENCE BETWEEN HIGHER VALUE DAILY MEASUREMENT SLI AND ACTUAL THERAPEUTIC SHOCK-DELIVERED VALUE. IF SLI EXCEEDS 145 OHMS WITH DELIVERED SHOCK, THE ENERGY IS TRUNCATED AND RESULTING SHOCK IS MONOPHASIC. JOHN WEBER IS THE SALES REP FOR THIS ACCOUNT. LOGGED ON BEHALF OF (B)(6). ACCORDING TO ADDITIONAL INFORMATION THE PATIENT PRESENTED TO THE HOSPITAL AFTER AN EPISODE OF VENTRICULAR FIBRILLATION (VF). DURING THE EPISODE, TWO ELECTRIC SHOCKS WERE DELIVERED BY THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. THE FIRST SHOCK DID NOT CONVERT THE RHYTHM, BUT THE SECOND DID. UPON INTERROGATION, A CODE 1005 WAS FOUND FOR A SHOCK INTO AN OPEN CIRCUIT. TS RECOMMENDED DEFIBRILLATION THRESHOLD (DFT) TEST TO ENSURE SHOCK EFFICACY. NO ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE OF THE PATIENT CONDITION. CURRENTLY, THIS LEAD REMAINS IN SERVICE. ACCORDING TO ADDITIONAL INFORMATION, THIS LEAD WAS CAPPED AND REPLACED WITH A NEW RV LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
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 SYSTEM EXHIBITED AN INCREASE IN SHOCKING IMPEDANCE MEASUREMENTS WHICH WERE NOW GREATER THAN 200 OHMS. VECTOR BREAKDOWN SHOWED ALL THREE CONTRIBUTING LEGS HAD SIGNIFICANTLY ELEVATED IMPEDANCE MEASUREMENTS. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DOCUMENTED THE CLINICAL OBSERVATIONS AND DISCUSSED TROUBLESHOOTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1633720 | ENDOTAK RELIANCE G | IMPLANTABLE LEAD | LWS | BOSTON SCIENTIFIC CORPORATION | 0185 | 227540 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Female | Required Intervention| H |