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Model Number 29631 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Blood Loss (2597)
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Event Date 01/21/2020 |
Event Type
Injury
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Manufacturer Narrative
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Unique device identifier (udi) is unavailable.No parts have been received by the manufacturer for evaluation.Device manufacture date is unavailable.Concomitant medical products: product id: 28322, serial/lot #: unk.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that, while in an electrode and probe placement procedure, the patient bled more than anticipated.It was suspected the issue was due to an increased incision size for the drill guide.There was a reported delay to the procedure of less than 1 hour due to this issue.It was later reported that no additional intervention was required for the increased bleeding.
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Search Alerts/Recalls
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