Model Number 429561 |
Device Problem
Pacing Problem (1439)
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Patient Problems
Muscle Weakness (1967); Heart Failure/Congestive Heart Failure (4446)
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Event Date 06/28/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.
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Event Description
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The patient suffered from attacks of weakness and exacerbation of heart failure.Pacing function of the device is thought to be the cardiovascular cause.The patient was hospitalized.Device has not yet been analyzed and remains implanted.Should additional information be received, this file will be updated.
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Manufacturer Narrative
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The physicians impression was sub-optimal activity of pacemaker without worsening of ejection fraction.According to the investigator, the sub-optimal activity was caused by incorrect programming of the device.Device remains implanted.The device is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.
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Search Alerts/Recalls
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