Model Number 4000 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Dizziness (2194); Numbness (2415); Balance Problems (4401); Speech Disorder (4415); Paresthesia (4421)
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Event Date 06/09/2022 |
Event Type
Injury
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Manufacturer Narrative
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This complaint included known side effects.
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Event Description
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The following side effects were reported following treatment: dizziness, impaired balance, numbness in the right side of mouth and tongue, and altered speech.
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Manufacturer Narrative
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This complaint includes known side effects for essential tremor treatment.No new risks were identified.No device malfunction was detected.Treatment parameters were in line with the typical range.
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Event Description
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The following side effects were reported following essential tremor treatment: balance impaired, paresthesia right side of mouth/tongue, dysphasia.
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Search Alerts/Recalls
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