BOSTON SCIENTIFIC NEUROMODULATION; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Device Problem
Use of Device Problem (1670)
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Patient Problems
Visual Disturbances (2140); No Code Available (3191)
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Event Date 01/12/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of implant: (b)(6) 2017 (exact date is unknown).
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Event Description
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It was reported that the patient experienced double vision following the activation of the dbs lead stimulation.An mri, magnetic resonance imaging, confirmed that the lead was 4mm too deep.The patient underwent a lead revision procedure three months post the initial implant in which the lead was repositioned.The patient indicated that the stimulation was then working, but that if the stimulation was increased it would cause pain on the sole of the left foot.A second mri, magnetic resonance imaging, confirmed that the right lead was not positioned well.No other information is available at this time.
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Event Description
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It was reported that the patient experienced double vision following the activation of the dbs lead stimulation.An mri, magnetic resonance imaging, confirmed that the lead was 4mm too deep.The patient underwent a lead revision procedure three months post the initial implant in which the lead was repositioned.The patient indicated that the stimulation was then working, but that if the stimulation was increased it would cause pain on the sole of the left foot.A second mri, magnetic resonance imaging, confirmed that the right lead was not positioned well.No other information is available at this time.Additional information was received that the patient was implant in (b)(6) 2017 of the cartesia lead db-2202, the exact model and the serial numbers are unknown, the revision took place in (b)(6) 2017.The patient is doing well postoperatively.The model and serial number of the device is unknown therefore, a record review could not be performed.The device remains implanted and will not be returned for evaluation; therefore, a technical product analysis of the device could not be completed.
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