Model Number 3346 |
Device Problem
Therapy Delivered to Incorrect Body Area (1508)
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Patient Problem
Undesired Nerve Stimulation (1980)
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Event Date 06/04/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.During processing of this complaint, attempts were made to obtain complete patient information.
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Event Description
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Related manufacturer reference number: 1627487-2021-12635.It was reported the patient experienced a tingling sensation at the extension header.Surgical intervention took place wherein the extensions were explanted and replaced.Tingling sensation has resolved.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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