Model Number MN10450-50A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Cerebrospinal Fluid Leakage (1772)
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Event Date 07/27/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).During processing of this complaint, attempts were made to obtain complete event and device information.The unique device identifier (udi #) is unknown because the lot and part number were not provided.
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Event Description
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It was reported during a procedure on (b)(6) 2022 a dural tear occurred.The patient experienced a headache and vomiting.Surgical intervention may take place at a later date to address the issue.
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Event Description
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Manufacturer report number: 1627487-2022-05278.Additional information received indicates a blood patch was performed and the patient's symptoms have resolved.
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Manufacturer Narrative
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A patient experienced a cerebrospinal fluid leak during a trial procedure was reported to abbott.Two leads were used instead of one lead.Csf leak occurred and blood patch was performed resolving the patient's symptoms.The results of the investigation are inconclusive as the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.
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Search Alerts/Recalls
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