Model Number 140-9800 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Respiratory Distress (2045); No Code Available (3191)
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Event Date 11/05/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Additional suspect medical device components involved in the event: product family: superion instruments, upn: (b)(4), model: 102-9800, lot: 203995.
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Event Description
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It was reported the patient began having respiratory issues during the procedure to implant the device.It was assessed that the patient had a reaction to the anesthesia.The procedure was aborted and the patient will be scheduled at a future date.Patient is fine post-operatively.
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Manufacturer Narrative
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H6 3191: no code available was used as there is no equivalent fda code for surgery.H2 if follow-up, what type - additional information.H6 evaluation method codes - analysis of production records 3331.H6 evaluation result codes - no device problem found 213.H6 evaluation conclusion codes - adverse event related to patient condition 50.Additional suspect medical device components involved in the event: product family: superion instruments, upn: (b)(4), model: 102-9800, lot: 203995.
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Event Description
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It was reported the patient began having respiratory issues during the procedure to implant the device.It was assessed that the patient had a reaction to the anesthesia.The procedure was aborted and the patient will be scheduled at a future date.Patient is fine post-operatively.
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Event Description
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It was reported the patient began having respiratory issues during the procedure to implant the device.It was assessed that the patient had a reaction to the anesthesia.The procedure was aborted and the patient will be scheduled at a future date.Patient is fine post-operatively.Additional information was received that the patient underwent the implant procedure.The patient is doing well post-operatively and is experiencing significant relief of neurogenic claudication symptoms.
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Search Alerts/Recalls
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