Model Number G154 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Syncope (1610); Anemia (1706); Atrial Flutter (1730); Dehydration (1807); Vaso-Vagal Response (2661); Syncope/Fainting (4411)
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Event Date 06/18/2019 |
Event Type
Injury
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Manufacturer Narrative
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The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.
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Event Description
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It was reported that the patient implanted with this cardiac resynchronization therapy defibrillator (crt-d) experienced a syncopal episode.Review of stored device memory noted no stored episodes that corresponded with the syncope, however, noted the patient was in an ongoing atrial tachy response (atr) mode switch due to atrial flutter.Available information indicates that this product remains implanted and in service.No additional adverse patient effects were reported.
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Event Description
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It was reported that the root cause of syncope was related to the patient's diagnosis of orthostatic hypotension with a possible vasovagal component.The patient was also diagnosed with several other medical issues unrelated to the device.
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Manufacturer Narrative
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As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
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Manufacturer Narrative
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As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.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.The device was then exposed to simulated heart load conditions, and the defibrillation, 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.
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Event Description
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It was reported that the patient implanted with this cardiac resynchronization therapy defibrillator (crt-d) experienced a syncopal episode.Review of stored device memory noted no stored episodes that corresponded with the syncope, however, noted the patient was in an ongoing atrial tachy response (atr) mode switch due to atrial flutter.Available information indicates that this product remains implanted and in service.No additional adverse patient effects were reported.It was reported that the root cause of syncope was related to the patient's diagnosis of orthostatic hypotension with a possible vasovagal component.The patient was also diagnosed with several other medical issues unrelated to the device.It was reported that the device was later explanted and replaced for reported normal battery depletion.The product has been received for analysis.
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Search Alerts/Recalls
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