Model Number 303-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Scarring (2061)
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Event Date 07/12/2019 |
Event Type
Injury
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Manufacturer Narrative
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Device evaluation is not necessary as the reported events of bleeding and scarring are not related to the functionality or delivery of therapy of the device.
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Event Description
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It was reported that during a patient's vns replacement surgery, there was "significant" bleeding caused by heavy scarring of the vagus to internal jugular vein.Due to the bleeding the surgeon considered re-implanting on the right vagus nerve; however, the bleeding was controlled and the physician implanted on the left vagus nerve.The patient historically twisted and manipulated their lead.Device evaluation is not necessary because the reported events of significant bleeding and scarring are not related to the functionality or delivery of therapy of the device.No further relevant information has been received to date.
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Event Description
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Follow up with the surgeon's office revealed that the bleeding was mild to moderate during initial dissection.It was stated that this eventually required intervention by vascular service and was successfully addressed with no residual adverse effects.It was stated that the physician's assessment on the root cause of the heavy scarring was related to the patient's body habitus, to the previous procedure, and to possibly unknown genetic factors.
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Search Alerts/Recalls
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