BOSTON SCIENTIFIC NEUROMODULATION VERCISE CARTESIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
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Model Number DB-2202-45 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
High Blood Pressure/ Hypertension (1908)
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Event Date 06/30/2023 |
Event Type
Injury
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Event Description
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It was reported that two days after the initial deep brain stimulation lead implant procedure, the patient experienced an event of hypertensive crisis.The patient was seen in the emergency department due to facial droop which was initially suspected to be a stroke but was later noted to be due to the parkinsons medication not working.The computed tomography (ct) scan found no significant findings.The hypertension was noted to be uncomplicated, and the event resolved, however, the patient was kept in the hospital longer as stage 2 of the implant procedure had been scheduled several days out.The patient was discharged the day after the stage 2 implant procedure in stable condition.
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Event Description
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It was reported that two days after the initial lead implant procedure, the patient experienced an event of hypertensive crisis.He was seen in the emergency department due to facial droop which was initially suspected to be a stroke but was later noted to be due to the parkinsons medication not working.The computed tomography (ct) scan found no significant findings.The hypertension was noted to be uncomplicated, and the event resolved, however, the patient was kept in the hospital longer as the stage 2 of the implant procedure had been scheduled several days out.The patient was discharged the day after the stage 2 implant procedure in stable condition.
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Manufacturer Narrative
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Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), lot: 7097433.
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Search Alerts/Recalls
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