Catalog Number TBD |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hematoma (1884)
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Event Date 09/21/2023 |
Event Type
Injury
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Event Description
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On (b)(6) 2023 during the placement of depth electrodes, an epidural hematoma occurred in the left frontal area and required another surgery.
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Manufacturer Narrative
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This report was past the 30-day date of awareness due to it was discovered from a customer survey and was not processed until 11-30-2023.Dr.(b)(6) was interviewed on 12/7/2023 about the reported hematoma.The investigation results revealed the root cause of the hematoma was not caused by the use of the depth electrodes, but rather due to the planning of surgical trajectories.
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Event Description
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On (b)(6) 2023, during the placement of depth electrodes, an epidural hematoma occurred in the left frontal area and required another surgery.
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Manufacturer Narrative
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This report was past the 30-day date of awareness due to it was discovered from a customer survey and was not processed until 11-30-2023.Dr.(b)(6) was interviewed on (b)(6) 2023 about the reported hematoma.The investigation results revealed the root cause of the hematoma was not caused by the use of the depth electrodes, but rather due to the planning of surgical trajectories.Updated on 01/02/2024: the customer stated there was no lasting impact on the patient.Our internal investigation concluded our devices were not the cause of the bleed and performed as intended.No specific catalog numbers, lot, or batches were identified.In addition, no product was available for return.The doctor associated with this case stated that ad-tech's devices did not cause the deficiency, that the deficiency was caused by planning of surgical trajectories.No further actions are needed at this time.
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Search Alerts/Recalls
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