Model Number 4000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Ambulation Difficulties (2544)
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Event Date 01/17/2024 |
Event Type
Injury
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Manufacturer Narrative
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No system malfunction.Treatment parameters were in line with the typical range.The system performance was found to be according to spec and as expected.No new risk has been recognized.If new details are received in the investigation for this incident, this report will be updated.
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Event Description
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Patient was treated for essential tremor with focused ultrasound on the right side to treat a left hand tremor.Gait disturbance was observed after the treatment.
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Event Description
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Patient was treated for essential tremor with focused ultrasound on the right side to treat a left hand tremor.Gait disturbance was observed after the treatment.
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Manufacturer Narrative
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No system malfunction.Treatment parameters were in line with the typical range.No new risk has been recognized.
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Search Alerts/Recalls
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