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Model Number 2104 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Malaise (2359)
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Event Date 02/19/2024 |
Event Type
Injury
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Event Description
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A barostim system was implanted on (b)(6) 2024.The patient "did not feel right" on 19-feb-2024, and presented to the emergency room on (b)(6) 2024.The patient was admitted to the hospital on (b)(6)2024.A stoke was ruled out.The physician was unconcerned if the patient's symptoms were related to the barostim implant or therapy, and the root cause was unable to be determined.It was noted that the patient had a history of non-compliance with medications.As of (b)(6) 2024, the patient had recovered, and barostim therapy was titrated successfully.No additional details were available.
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Manufacturer Narrative
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The results of the investigation are inconclusive at this time, and the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.The device history and sterilization record for this device serial number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.(b)(4).
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Search Alerts/Recalls
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