BOSTON SCIENTIFIC NEUROMODULATION VERTIFLEX INSTRUMENT PLATFORM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
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Model Number 140-9800 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypoxia (1918); Respiratory Insufficiency (4462)
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Event Date 02/17/2022 |
Event Type
Injury
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Event Description
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It was reported the patient's oxygen saturation levels began to drop during a procedure to implant the superion indirect decompression spacer.The patient had been sedated, and an incision had been made over the l4-l5 interspace; the physician had positioned dilator 1 properly at the time the patient's oxygen levels began to drop, and the anesthesiologist assessed that the procedure needed to be aborted.The incision was packed, and once the patient was repositioned on their back, oxygen was forced via artificial manual breathing unit (ambu) bag.The patient's oxygen levels were normalized and the patient was conscious.
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Event Description
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It was reported the patient's oxygen saturation levels began to drop during a procedure to implant the superion indirect decompression spacer.The patient had been sedated, and an incision had been made over the l4-l5 interspace; the physician had positioned dilator 1 properly at the time the patient's oxygen levels began to drop, and the anesthesiologist assessed that the procedure needed to be aborted.The incision was packed, and once the patient was repositioned on their back, oxygen was forced via artificial manual breathing unit (ambu) bag.The patient's oxygen levels were normalized and the patient was conscious.
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