BOSTON SCIENTIFIC NEUROMODULATION VERCISE; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number DB-1110C |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Undesired Nerve Stimulation (1980); Neurological Deficit/Dysfunction (1982); Seizures (2063); No Code Available (3191)
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Event Date 10/22/2020 |
Event Type
Injury
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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: (b)(4), model: db-2201-30dc, serial: (b)(4), batch: 18431966 and 18431966.
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Event Description
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It was reported that the patient experienced unpleasant sensations, undesired stimulation, while charging.The patient indicated that she felt unwell and was unable to continue charging.After one such episode while charging the patient went to the emergency room, and discharged the same day.It was indicated that it may have been a possible dystonic seizure.It is unknown if any intervention was provided during the hospitalization.The patient is doing well.
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Event Description
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It was reported that the patient experienced unpleasant sensations, undesired stimulation, while charging.The patient indicated that she felt unwell and was unable to continue charging.After one such episode while charging the patient went to the emergency room, and discharged the same day.It was indicated that it may have been a possible dystonic seizure.It is unknown if any intervention was provided during the hospitalization.The patient is doing well.
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Manufacturer Narrative
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Block h6 patient code 3191: no code available was used as there is no equivalent fda code for additional intervention.
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Search Alerts/Recalls
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