Model Number RNS-320-K - FGI |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Drug Resistant Bacterial Infection (4553)
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Event Date 01/13/2023 |
Event Type
Injury
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Event Description
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The patient presented at her postoperative appointment (approximately 6 weeks after her implant, (b)(6) 2023) drainage from incision site.Mri was ordered and did not show a deep infection.The doctor reported that this was likely a stitch abscess which resolved no additional drainage was reported.Treatment included hospitalization and 5 days for iv (vanc/ceftriaxone/flagyl) while cultures were pending.Once the culture results were received the patient was sent home with oral antibiotics.The patient is currently home continuing with the oral antibiotic treatment.Diagnosed as an incisional infection.
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Manufacturer Narrative
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(b)(4).The rns neurostimulator and leads remain implanted and programmed for use.
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Manufacturer Narrative
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B5 description was updated.(b)(4).The rns neurostimulator and leads remain implanted and programmed for use.
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Event Description
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Description was updated: the patient presented at her postoperative appointment (approximately 6 weeks after her implant, (b)(6) 2023) with drainage from the incision site.An mri was ordered and did not show a deep infection.The doctor reported that this was likely a stitch abscess which resolved.No additional drainage was reported.Treatment included hospitalization x 5 days for iv (vanc/ceftriaxone/flagyl) while cultures were pending.Once the culture results were received the patient was sent home with oral antibiotics.The patient is currently home continuing with the oral antibiotic treatment.This was diagnosed as an incisional infection.
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Search Alerts/Recalls
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