Model Number A209 |
Device Problems
Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
Atrial Tachycardia (1731)
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Event Date 11/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This investigation is ongoing.Upon additional information this investigation will be updated.
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Event Description
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It was reported that an inappropriate shock was delivered due to a fast irregular arrhythmia.A review by technical services (ts) noted that the fast rhythm observed occurred due to a fast conducted atrial tachyarrhythmia.It was noted that the device was reprogrammed from secondary to primary vector.Ts discussed performing in office troubleshooting for further testing and sensor optimization.No adverse patient effects were reported.
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Manufacturer Narrative
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This investigation is ongoing.Upon additional information this investigation will be updated.
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Event Description
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It was reported that an inappropriate shock was delivered due to a fast irregular arrhythmia.A review by technical services (ts) noted that the fast rhythm observed occurred due to a fast conducted atrial tachyarrhythmia.It was noted that the device was reprogrammed from secondary to primary vector.Ts discussed performing in office troubleshooting for further testing and sensor optimization.No adverse patient effects were reported.
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Search Alerts/Recalls
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