BOSTON SCIENTIFIC NEUROMODULATION SURETEK; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number DB-4600C |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nausea (1970); Confusion/ Disorientation (2553); Speech Disorder (4415)
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Event Date 08/08/2023 |
Event Type
Injury
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Event Description
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It was reported that the deep brain stimulation (dbs) patient experienced symptoms of nausea, difficulty with speech, and mild confusion during a stage one dbs implant procedure.The patient was sedated with local anesthesia and the procedure was rescheduled.The patient was treated with an intravenous line (iv) medication and their symptoms improved.The patients symptoms continued even after the stimulation was turned off.The physician examined the patients face and did not see any asymmetry nor did they detect any strength imbalances that may indicate a brain bleed.The patients blood pressure remained normal during the entire procedure.The physician decided to stop the procedure prior to any of the leads being implanted.The patient was discharged from the hospital the next day and was back to normal.The cause of the difficulty with speech and mild confusion symptoms are unknown.
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Event Description
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It was reported that the deep brain stimulation (dbs) patient experienced symptoms of nausea, difficulty with speech, and mild confusion.The patient was treated with an intravenous line (iv) medication and their symptoms improved.The patients symptoms continued even after the stimulation was turned off.The physician examined the patients face and did not see any asymmetry nor did they detect any strength imbalances that may indicate a brain bleed.The patients blood pressure remained normal during the entire procedure.The physician decided to stop the procedure prior to any of the leads being implanted.The patient was discharged from the hospital the next day and was back to normal.The cause of the difficulty with speech and mild confusion symptoms are unknown.
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