ENDOTAK RELIANCE G
Report
- Report Number
- 2124215-2010-13130
- Event Type
- Injury
- Date Received
- July 27, 2010
- Date of Event
- June 14, 2010
- Report Date
- August 5, 2020
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- PMA / PMN Number
- P910073
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
BOSTON SCIENTIFIC RECEIVED NEW INFORMATION. THE SHOCK IMPEDANCE MEASUREMENTS IN THE DAILY MEASUREMENTS HAD CONSISTENTLY BEEN HIGH, OUT-OF-RANGE. THE PATIENT WAS BROUGHT IN TO EVALUATE THE SYSTEM AGAIN. COMMANDED SHOCKS WERE DELIVERED, WITH NORMAL SHOCK IMPEDANCE MEASUREMENTS OBSERVED. ONE COMMANDED SHOCK LEAD IMPEDANCE TEST (SLIT) PERFORMED AFTER THE COMMANDED SHOCKS WERE DELIVERED PRODUCED A SHOCK IMPEDANCE MEASUREMENT OF 44 OHMS; HOWEVER, SLIT IN EACH SHOCK CONFIGURATION PRIOR TO DELIVERY OF THE COMMANDED SHOCKS WERE ALL GREATER THAN 125 OHMS. THE PHYSICIAN WILL CONTINUE TO MONITOR THE SHOCK IMPEDANCE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND LEAD REMAIN IN SERVICE.
(B)(4). BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION THAT ALERTS FOR OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS CONTINUED TO BE RECORDED. THE PATIENT WAS SEEN FOR DEVICE FOLLOW-UPS EVERY THREE MONTHS, AS DESCRIBED IN LABELING. THE PATIENT WAS SEEN IN OFFICE ON AUGUST 7, 2014 AND THE SHOCK LEAD IMPEDANCE TEST PRODUCED A MEASUREMENT OF 136 OHMS. THE SYSTEM WILL CONTINUE TO BE MONITORED. NO CHANGES WERE MADE TO THE SYSTEM, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.
TECHNICAL SERVICES EXPLAINED THE DIFFERENCE IN THE SHOCK LEAD IMPEDANCE TEST FOR DAILY MEASUREMENTS AND IN THE DELIVERY OF A HIGH ENERGY SHOCK. IT APPEARED THAT THE DISTAL COIL WAS WHERE THE POTENTIAL SETSCREW ISSUE WAS OCCURRING. IT WAS THE PHYSICIAN'S DISCRETION WHETHER AN INVASIVE PROCEDURE WAS PERFORMED TO VERIFY CONNECTIONS OR TO CONTINUE MONITORING THE DEVICE. IT WAS LATER REPORTED THAT DURING THE TROUBLESHOOTING AND DFTS, THE DEVICE WAS REPROGRAMMED WITH A LOWER RATE CUT OFF AND INADVERTENTLY LEFT THAT WAY. MULTIPLE NONSUSTAINED AND VT-1 ZONE EPISODES WERE STORED, RESULTING IN THE ELECTROGRAMS FROM PREVIOUS EPISODES BEING OVERWRITTEN. THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY FOR SVT, BUT NO SHOCKS, DUE TO THIS ISSUE. THE DEVICE WAS PROGRAMMED BACK TO MORE APPROPRIATE SETTINGS. THE FIELD REPRESENTATIVE REPORTED THAT THE PHYSICIAN WAS SATISFIED WITH THE IMPEDANCE MEASUREMENTS FOR THE DELIVERED SHOCKS AND WOULD CONTINUE TO MONITOR THE DAILY MEASUREMENTS. IT WAS UNDERSTOOD THAT LATITUDE WOULD CONTINUE TO ISSUE RED ALERTS FOR THE OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. AS OF TODAY, NO INVASIVE PROCEDURE WAS PLANNED AND THE DEVICE AND LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
(B)(4). EVIDENCE SUGGESTS THE DEVICE AND LEAD REMAIN IMPLANTED AND IN SERVICE. THIS REPORT WILL BE UPDATED WHEN ADDITIONAL INFORMATION IS RECEIVED.
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS TRANSVENOUS DEFIBRILLATION LEAD AND ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. A RED ALERT WAS ISSUED IN LATITUDE FOR DAILY SHOCK IMPEDANCE MEASUREMENTS THAT WERE >125 OHMS. TROUBLE SHOOTING WAS PERFORMED AND CONFIRMED THAT NOISE COULD BE CREATED ON THE SHOCK CHANNEL WITH POCKET MANIPULATION, DEEP BREATHING AND BEARING DOWN. THE ATRIAL AND VENTRICULAR CHANNELS WERE CLEAN. TECHNICAL SERVICES AND THE PHYSICIAN BELIEVED THIS TO BE A SETSCREW ISSUE. AN X-RAY WAS RECOMMENDED TO EVALUATE THE LEAD AND THE CONNECTIONS, TO SEE IF THE TERMINAL PIN COULD BE SEEN AT THE END OF THE HEADER. THE FIELD REPRESENTATIVE REPORTED THAT TWO COMMANDED SHOCKS WERE DELIVERED, WITH ACCEPTABLE SHOCK IMPEDANCE MEASUREMENTS.
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND ASSOCIATED DEFIBRILLATION LEAD EXHIBITED OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. A RED ALERT WAS ISSUED IN LATITUDE FOR DAILY SHOCK IMPEDANCE MEASUREMENTS THAT WERE GREATER THAN 125 OHMS. TROUBLE SHOOTING WAS PERFORMED AND CONFIRMED THAT NOISE COULD BE CREATED ON THE SHOCK CHANNEL WITH POCKET MANIPULATION, DEEP BREATHING AND BEARING DOWN. THE ATRIAL AND VENTRICULAR CHANNELS WERE CLEAN. TECHNICAL SERVICES AND THE PHYSICIAN BELIEVED THIS TO BE A SETSCREW ISSUE. AN X-RAY WAS RECOMMENDED TO EVALUATE THE LEAD AND THE CONNECTIONS, TO SEE IF THE TERMINAL PIN COULD BE SEEN AT THE END OF THE HEADER. THE FIELD REPRESENTATIVE REPORTED THAT TWO COMMANDED SHOCKS WERE DELIVERED, WITH ACCEPTABLE SHOCK IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES EXPLAINED THE DIFFERENCE IN THE SHOCK LEAD IMPEDANCE TEST FOR DAILY MEASUREMENTS AND IN THE DELIVERY OF A HIGH ENERGY SHOCK. IT APPEARED THAT THE DISTAL COIL WAS WHERE THE POTENTIAL SETSCREW ISSUE WAS OCCURRING. IT WAS THE PHYSICIAN'S DISCRETION WHETHER AN INVASIVE PROCEDURE WAS PERFORMED TO VERIFY CONNECTIONS OR TO CONTINUE MONITORING THE DEVICE. IT WAS LATER REPORTED THAT DURING THE TROUBLE SHOOTING AND DFTS, THE DEVICE WAS REPROGRAMMED WITH A LOWER RATE CUT OFF AND INADVERTENTLY LEFT THAT WAY. MULTIPLE NONSUSTAINED AND VT-1 ZONE EPISODES WERE STORED, RESULTING IN THE ELECTROGRAMS FROM PREVIOUS EPISODES BEING OVERWRITTEN. THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY FOR SVT, BUT NO SHOCKS, DUE TO THIS ISSUE. THE DEVICE WAS PROGRAMMED BACK TO MORE APPROPRIATE SETTINGS. THE FIELD REPRESENTATIVE REPORTED THAT THE PHYSICIAN WAS SATISFIED WITH THE IMPEDANCE MEASUREMENTS FOR THE DELIVERED SHOCKS AND WOULD CONTINUE TO MONITOR THE DAILY MEASUREMENTS. IT WAS UNDERSTOOD THAT LATITUDE WOULD CONTINUE TO ISSUE RED ALERTS FOR THE OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. AS OF TODAY, NO INVASIVE PROCEDURE WAS PLANNED AND THE DEVICE AND LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. BOSTON SCIENTIFIC RECEIVED NEW INFORMATION. THE SHOCK IMPEDANCE MEASUREMENTS IN THE DAILY MEASUREMENTS HAD CONSISTENTLY BEEN HIGH, OUT-OF-RANGE. THE PATIENT WAS BROUGHT IN TO EVALUATE THE SYSTEM AGAIN. COMMANDED SHOCKS WERE DELIVERED, WITH NORMAL SHOCK IMPEDANCE MEASUREMENTS OBSERVED. ONE COMMANDED SHOCK LEAD IMPEDANCE TEST (SLIT) PERFORMED AFTER THE COMMANDED SHOCKS WERE DELIVERED PRODUCED A SHOCK IMPEDANCE MEASUREMENT OF 44 OHMS; HOWEVER, SLIT IN EACH SHOCK CONFIGURATION PRIOR TO DELIVERY OF THE COMMANDED SHOCKS WERE ALL GREATER THAN 125 OHMS. THE PHYSICIAN WILL CONTINUE TO MONITOR THE SHOCK IMPEDANCE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND LEAD REMAIN IN SERVICE. BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION THAT ALERTS FOR OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS CONTINUED TO BE RECORDED. THE PATIENT WAS SEEN FOR DEVICE FOLLOW-UPS EVERY THREE MONTHS, AS DESCRIBED IN LABELING. THE PATIENT WAS SEEN IN OFFICE ON (B)(6) 2014 AND THE SHOCK LEAD IMPEDANCE TEST PRODUCED A MEASUREMENT OF 136 OHMS. THE SYSTEM WILL CONTINUE TO BE MONITORED. NO CHANGES WERE MADE TO THE SYSTEM, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. IN MARCH 2020 IT WAS REPORTED THAT THIS DEVICE HAD REACHED EXPLANT BATTERY STATUS IN JANUARY 2020. THE DEVICE WAS BEING MONITORED IN LATITUDE; HOWEVER, DUE TO THE BATTERY STATUS OF THE DEVICE, REMOTE MONITORING AND RADIO FREQUENCY (RF) TELEMETRY WERE NOW DISABLED TO CONSERVE THE REMAINING BATTERY CAPACITY. TECHNICAL SERVICES CONFIRMED THE SHOCK IMPEDANCES VALUES WERE STILL HIGH, OUT-OF-RANGE WITH THE LAST REPORTED MEASUREMENT OF 153 OHMS. THE FACILITY WAS TRYING TO DETERMINE THE BEST PLAN FOR DEVICE REPLACEMENT AMID THE COVID-19 PANDEMIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE G | PERMANENT DEFIBRILLATOR ELECTRODES | LWS | BOSTON SCIENTIFIC CORPORATION | 0185 | 238796 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Life Threatening| R | 0185| 4136| E110| E110| 0185| 4136 |