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Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Weakness (2145); Numbness (2415)
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Event Date 11/16/2020 |
Event Type
Injury
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Event Description
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Related manufacturer reference number:1627487-2020-48674.It was reported patient was experiencing numbness and weakness in arms due to having placed the leads anterior.As such, surgical intervention took place where the leads and anchors were explanted.
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Search Alerts/Recalls
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