Model Number A219 |
Device Problems
Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581); Migration (4003)
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Patient Problem
Electric Shock (2554)
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Event Date 03/26/2023 |
Event Type
Injury
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Manufacturer Narrative
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This report will be updated when additional information is received.
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Event Description
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It was reported that the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) system received an inappropriate shock from the device.The patient presented to the emergency department (ed).It was noted that r-wave amplitudes were significantly decreased and the shock appeared to be due to artifact and a baseline shift.Device data was submitted to technical services for review.Upon review of the stored episodes, it was noted a smart pass episode occurred on (b)(6) 2023 showing significant artifact and a reduced r-wave signal.There were six untreated episodes showing the same artifact and flat baseline.It was then reported that the device was moving in the pocket, such that the patient would need to flip it back into place.The patient was seen and noise was able to be created in the primary and alternate vectors, but not in secondary.X-rays were reviewed and it appeared the electrode was fully inserted into the device header, and the electrode did not appear to have any acute bends.The device was programmed off after the inappropriate shock.The secondary vector at a gain of 2x appeared most appropriate.The physician was planning to perform additional troubleshooting in secondary, to see if any signal disturbances could be induced.However, understanding that the poor sensing could be due to the device being loose in the pocket, the physician may leave therapy off and replace the s-icd system with a transvenous device.Additional troubleshooting was performed in the secondary vector and data was submitted to technical services.It was noted the r-wave amplitudes were quite variable during testing, ranging from 1.0mv to less than 0.5mv.Sensing did appear appropriate and smart pass was able to be activated, but was likely to become disabled due to the small amplitudes observed.Technical services recommended weekly follow ups for a period of time to monitor the nsr to tachy counters and any stored episodes.The local sales representative noted the device could be moved in the pocket, not flipped, but rotated.As of today, therapy was programmed back on and smart pass remained enabled.No additional adverse patient effects were reported outside of the inappropriate shock that was received.The device and electrode remain implanted and in service.Additional information was received indicating smart pass had disabled, due to low amplitude r-waves and long intervals.Technical services agreed with leaving smart pass off and continuing to monitor the patient and device in latitude to confirm sensing in the secondary vector remained appropriate.
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Manufacturer Narrative
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This report will be updated when additional information is received.If pertinent information is provided in the future, a supplemental report will be submitted.
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Event Description
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It was reported that the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) system received an inappropriate shock from the device.The patient presented to the emergency department (ed).It was noted that r-wave amplitudes were significantly decreased and the shock appeared to be due to artifact and a baseline shift.Device data was submitted to technical services for review.Upon review of the stored episodes, it was noted a smart pass episode occurred on march 26 showing significant artifact and a reduced r-wave signal.There were six untreated episodes showing the same artifact and flat baseline.It was then reported that the device was moving in the pocket, such that the patient would need to flip it back into place.The patient was seen and noise was able to be created in the primary and alternate vectors, but not in secondary.X-rays were reviewed and it appeared the electrode was fully inserted into the device header, and the electrode did not appear to have any acute bends.The device was programmed off after the inappropriate shock.The secondary vector at a gain of 2x appeared most appropriate.The physician was planning to perform additional troubleshooting in secondary, to see if any signal disturbances could be induced.However, understanding that the poor sensing could be due to the device being loose in the pocket, the physician may leave therapy off and replace the s-icd system with a transvenous device.Additional troubleshooting was performed in the secondary vector and data was submitted to technical services.It was noted the r-wave amplitudes were quite variable during testing, ranging from 1.0mv to less than 0.5mv.Sensing did appear appropriate and smart pass was able to be activated, but was likely to become disabled due to the small amplitudes observed.Technical services recommended weekly follow ups for a period of time to monitor the nsr to tachy counters and any stored episodes.The local sales representative noted the device could be moved in the pocket, not flipped, but rotated.As of today, therapy was programmed back on and smart pass remained enabled.No additional adverse patient effects were reported outside of the inappropriate shock that was received.The device and electrode remain implanted and in service.Additional information was received indicating smart pass had disabled, due to low amplitude r-waves and long intervals.Technical services agreed with leaving smart pass off and continuing to monitor the patient and device in latitude to confirm sensing in the secondary vector remained appropriate.Additional information was received.The device stored an atrial fibrillation (af) episode showing non-physiologic artifact noise and loss of sensing.Technical services reviewed the data in latitude and confirmed the nsr to tachy counters had increased again.It was noted the episode was recorded at 4:00 am and the patient had to flip the device back into place again.At this time, technical services recommended programming the device off and considering replacing the system or moving to a transvenous device.The physician was concerned about the electrode integrity, but the episodes were not showing a morphology consistent with the advisory behavior, and the movement of the device was likely causing the sensing observations.The s-icd was deactivated and the physician will implant a transvenous system at a later date.Currently, the patient's ejection fraction (ef) has improved, and the patient is being treated for myeloma, so the physician was not considering an urgent replacement.
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Manufacturer Narrative
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This report will be updated when additional information is received.If pertinent information is provided in the future, a supplemental report will be submitted.The product has been received for analysis.This report will be updated upon completion of analysis.
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Event Description
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It was reported that the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) system received an inappropriate shock from the device.The patient presented to the emergency department (ed).It was noted that r-wave amplitudes were significantly decreased and the shock appeared to be due to artifact and a baseline shift.Device data was submitted to technical services for review.Upon review of the stored episodes, it was noted a smart pass episode occurred on march 26 showing significant artifact and a reduced r-wave signal.There were six untreated episodes showing the same artifact and flat baseline.It was then reported that the device was moving in the pocket, such that the patient would need to flip it back into place.The patient was seen and noise was able to be created in the primary and alternate vectors, but not in secondary.X-rays were reviewed and it appeared the electrode was fully inserted into the device header, and the electrode did not appear to have any acute bends.The device was programmed off after the inappropriate shock.The secondary vector at a gain of 2x appeared most appropriate.The physician was planning to perform additional troubleshooting in secondary, to see if any signal disturbances could be induced.However, understanding that the poor sensing could be due to the device being loose in the pocket, the physician may leave therapy off and replace the s-icd system with a transvenous device.Additional troubleshooting was performed in the secondary vector and data was submitted to technical services.It was noted the r-wave amplitudes were quite variable during testing, ranging from 1.0mv to less than 0.5mv.Sensing did appear appropriate and smart pass was able to be activated, but was likely to become disabled due to the small amplitudes observed.Technical services recommended weekly follow ups for a period of time to monitor the nsr to tachy counters and any stored episodes.The local sales representative noted the device could be moved in the pocket, not flipped, but rotated.As of today, therapy was programmed back on and smart pass remained enabled.No additional adverse patient effects were reported outside of the inappropriate shock that was received.The device and electrode remain implanted and in service.Additional information was received indicating smart pass had disabled, due to low amplitude r-waves and long intervals.Technical services agreed with leaving smart pass off and continuing to monitor the patient and device in latitude to confirm sensing in the secondary vector remained appropriate.Additional information was received.The device stored an atrial fibrillation (af) episode showing non-physiologic artifact noise and loss of sensing.Technical services reviewed the data in latitude and confirmed the nsr to tachy counters had increased again.It was noted the episode was recorded at 4:00 am and the patient had to flip the device back into place again.At this time, technical services recommended programming the device off and considering replacing the system or moving to a transvenous device.The physician was concerned about the electrode integrity, but the episodes were not showing a morphology consistent with the advisory behavior, and the movement of the device was likely causing the sensing observations.The s-icd was deactivated and the physician will implant a transvenous system at a later date.Currently, the patient's ejection fraction (ef) has improved, and the patient is being treated for myeloma, so the physician was not considering an urgent replacement.The s-icd system was explanted and was returned for analysis.No additional adverse patient effects were reported.
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Manufacturer Narrative
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This report will be updated when additional information is received.If pertinent information is provided in the future, a supplemental report will be submitted.The product has been received for analysis.This report will be updated upon completion of analysis.The returned device was thoroughly inspected and analyzed.Visual inspection identified no anomalies.The device was able to be interrogated and a memory download was performed successfully.The device was then exposed to simulated heart load conditions, and the defibrillation and sensing functions were tested.The device operated appropriately, according to its performance specifications with no out of range measurements or interruptions in therapy output.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
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Event Description
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It was reported that the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) system received an inappropriate shock from the device.The patient presented to the emergency department (ed).It was noted that r-wave amplitudes were significantly decreased and the shock appeared to be due to artifact and a baseline shift.Device data was submitted to technical services for review.Upon review of the stored episodes, it was noted a smart pass episode occurred on march 26 showing significant artifact and a reduced r-wave signal.There were six untreated episodes showing the same artifact and flat baseline.It was then reported that the device was moving in the pocket, such that the patient would need to flip it back into place.The patient was seen and noise was able to be created in the primary and alternate vectors, but not in secondary.X-rays were reviewed and it appeared the electrode was fully inserted into the device header, and the electrode did not appear to have any acute bends.The device was programmed off after the inappropriate shock.The secondary vector at a gain of 2x appeared most appropriate.The physician was planning to perform additional troubleshooting in secondary, to see if any signal disturbances could be induced.However, understanding that the poor sensing could be due to the device being loose in the pocket, the physician may leave therapy off and replace the s-icd system with a transvenous device.Additional troubleshooting was performed in the secondary vector and data was submitted to technical services.It was noted the r-wave amplitudes were quite variable during testing, ranging from 1.0mv to less than 0.5mv.Sensing did appear appropriate and smart pass was able to be activated, but was likely to become disabled due to the small amplitudes observed.Technical services recommended weekly follow ups for a period of time to monitor the nsr to tachy counters and any stored episodes.The local sales representative noted the device could be moved in the pocket, not flipped, but rotated.As of today, therapy was programmed back on and smart pass remained enabled.No additional adverse patient effects were reported outside of the inappropriate shock that was received.The device and electrode remain implanted and in service.Additional information was received indicating smart pass had disabled, due to low amplitude r-waves and long intervals.Technical services agreed with leaving smart pass off and continuing to monitor the patient and device in latitude to confirm sensing in the secondary vector remained appropriate.Additional information was received.The device stored an atrial fibrillation (af) episode showing non-physiologic artifact noise and loss of sensing.Technical services reviewed the data in latitude and confirmed the nsr to tachy counters had increased again.It was noted the episode was recorded at 4:00 am and the patient had to flip the device back into place again.At this time, technical services recommended programming the device off and considering replacing the system or moving to a transvenous device.The physician was concerned about the electrode integrity, but the episodes were not showing a morphology consistent with the advisory behavior, and the movement of the device was likely causing the sensing observations.The s-icd was deactivated and the physician will implant a transvenous system at a later date.Currently, the patient's ejection fraction (ef) has improved, and the patient is being treated for myeloma, so the physician was not considering an urgent replacement.The s-icd system was explanted and was returned for analysis.No additional adverse patient effects were reported.
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