PERCIVA ICD VR
Report
- Report Number
- 2124215-2022-36887
- Event Type
- Injury
- Date Received
- September 20, 2022
- Date of Event
- June 7, 2022
- Report Date
- November 4, 2022
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- PMA / PMN Number
- P960040/S385
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE. UPON REVIEW OF THE DEVICE DATA BY TECHNICAL SERVICES (TS), THE HIGH OUT OF RANGE SHOCK IMPEDANCE WAS CONFIRMED AND IT WAS ALSO DISCUSSED THAT THERE IS NOISE RECORDED ON THE SHOCK ELECTROGRAM (EGM). FURTHER RECOMMENDATIONS AND TROUBLESHOOTING OPTIONS WERE PROVIDED BY TS. THE ICD SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE. UPON REVIEW OF THE DEVICE DATA BY TECHNICAL SERVICES (TS), THE HIGH OUT OF RANGE SHOCK IMPEDANCE WAS CONFIRMED AND IT WAS ALSO DISCUSSED THAT THERE IS NOISE RECORDED ON THE SHOCK ELECTROGRAM (EGM). FURTHER RECOMMENDATIONS AND TROUBLESHOOTING OPTIONS WERE PROVIDED BY TS. ADDITIONAL INFORMATION PROVIDED INDICATES THAT ACCORDING TO THE CLINIC INVESTIGATION THE RIGHT ATRIAL (RA) COIL COULD BE IMPAIRED DUE TO THE HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS IN THE RA COIL TO CAN CONFIGURATION. FURTHER REVIEW AND ADVICE FROM TS WAS REQUESTED. TS DISCUSSED THAT THE SHOCK IMPEDANCE MEASUREMENTS ARE COMPLETELY SATURATED, THEREFORE, THE EXACT IMPEDANCE VALUES ARE NOT KNOWN AND THE PERCENTAGE OF ENERGY DELIVERY TO THE PATIENT CANNOT BE CALCULATED AND IT MAY BE POSSIBLE THE CONDUCTOR IS FRACTURED. THERE APPEAR TO BE NO FURTHER PROGRAMMING ALTERNATIVES THAT CAN BE APPLIED AND INVASIVE ALTERNATIVES ARE TO BE CONSIDERED. THE ICD SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE. UPON REVIEW OF THE DEVICE DATA BY TECHNICAL SERVICES (TS), THE HIGH OUT OF RANGE SHOCK IMPEDANCE WAS CONFIRMED AND IT WAS ALSO DISCUSSED THAT THERE IS NOISE RECORDED ON THE SHOCK ELECTROGRAM (EGM). FURTHER RECOMMENDATIONS AND TROUBLESHOOTING OPTIONS WERE PROVIDED BY TS. ADDITIONAL INFORMATION PROVIDED INDICATES THAT ACCORDING TO THE CLINIC INVESTIGATION THE RIGHT ATRIAL (RA) COIL COULD BE IMPAIRED DUE TO THE HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS IN THE RA COIL TO CAN CONFIGURATION. FURTHER REVIEW AND ADVICE FROM TS WAS REQUESTED. TS DISCUSSED THAT THE SHOCK IMPEDANCE MEASUREMENTS ARE COMPLETELY SATURATED, THEREFORE, THE EXACT IMPEDANCE VALUES ARE NOT KNOWN AND THE PERCENTAGE OF ENERGY DELIVERY TO THE PATIENT CANNOT BE CALCULATED AND IT MAY BE POSSIBLE THE CONDUCTOR IS FRACTURED. THERE APPEAR TO BE NO FURTHER PROGRAMMING ALTERNATIVES THAT CAN BE APPLIED AND INVASIVE ALTERNATIVES ARE TO BE CONSIDERED. THE ICD SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION PROVIDED INDICATES THE PATIENT DEVICE IS EMITTING BEEPING TONES, WHICH ARE SUSPECTED TO BE DUE TO THE HIGH OUT OF RANGE SHOCK IMPEDANCE. TS REVIEWED THE DEVICE DATA AND CONFIRMED THE CAUSE OF THE DEVICE BEEPING TONES IS THE OUT OF RANGE SHOCK IMPEDANCE. IN ADDITION, IT WAS MENTIONED THAT THE CLINIC IS PLANNING TO PERFORM DEFIBRILLATION THRESHOLD (DFT) TEST FOR THIS DEVICE SYSTEM. THE LEAD WAS CONFIRMED TO BE A NON-BOSTON SCIENTIFIC PRODUCT.
IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE. UPON REVIEW OF THE DEVICE DATA BY TECHNICAL SERVICES (TS), THE HIGH OUT OF RANGE SHOCK IMPEDANCE WAS CONFIRMED AND IT WAS ALSO DISCUSSED THAT THERE IS NOISE RECORDED ON THE SHOCK ELECTROGRAM (EGM). FURTHER RECOMMENDATIONS AND TROUBLESHOOTING OPTIONS WERE PROVIDED BY TS. ADDITIONAL INFORMATION PROVIDED INDICATES THAT ACCORDING TO THE CLINIC INVESTIGATION THE RIGHT ATRIAL (RA) COIL COULD BE IMPAIRED DUE TO THE HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS IN THE RA COIL TO CAN CONFIGURATION. FURTHER REVIEW AND ADVICE FROM TS WAS REQUESTED. TS DISCUSSED THAT THE SHOCK IMPEDANCE MEASUREMENTS ARE COMPLETELY SATURATED, THEREFORE, THE EXACT IMPEDANCE VALUES ARE NOT KNOWN AND THE PERCENTAGE OF ENERGY DELIVERY TO THE PATIENT CANNOT BE CALCULATED AND IT MAY BE POSSIBLE THE CONDUCTOR IS FRACTURED. THERE APPEAR TO BE NO FURTHER PROGRAMMING ALTERNATIVES THAT CAN BE APPLIED AND INVASIVE ALTERNATIVES ARE TO BE CONSIDERED. ADDITIONAL INFORMATION PROVIDED INDICATES THE PATIENT DEVICE IS EMITTING BEEPING TONES, WHICH ARE SUSPECTED TO BE DUE TO THE HIGH OUT OF RANGE SHOCK IMPEDANCE. TS REVIEWED THE DEVICE DATA AND CONFIRMED THE CAUSE OF THE DEVICE BEEPING TONES IS THE OUT OF RANGE SHOCK IMPEDANCE. IN ADDITION, IT WAS MENTIONED THAT THE CLINIC IS PLANNING TO PERFORM DEFIBRILLATION THRESHOLD (DFT) TEST FOR THIS DEVICE SYSTEM. THE LEAD WAS CONFIRMED TO BE A NON-BOSTON SCIENTIFIC PRODUCT. UPON THE PATIENT'S VISIT TO THE CLINIC, THE PATIENT WAS PUT UNDER GENERAL ANESTHETIC. IT WAS CLARIFIED THAT THE ANTERIOR COIL OF THE LEAD WAS BROKEN. IT WAS THEN TRIED TO INDUCE THE PATIENT INTO SUSTAINED VENTRICULAR ARRHYTHMIA, HOWEVER, NONE OF THE USED METHODS WERE SUCCESSFUL TO SUSTAIN A VENTRICULAR ARRHYTHMIA FOR MORE THAN 2 SECONDS. AS A RESULT, THE CONSULTANTS WILL REVIEW THE SITUATION TO DETERMINE IF THE PATIENT WILL RECEIVE A NEW ANTERIOR COIL. THE ICD SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2693756 | PERCIVA ICD VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | BOSTON SCIENTIFIC CORPORATION | D400 | 111401 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |