Model Number 3116 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nausea (1970); Vomiting (2144); Therapeutic Response, Decreased (2271); Anxiety (2328)
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Event Date 01/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for gastric stimulation and gastrointestinal/pelvic floor issues.It was reported that the patient had a return of symptoms, some nausea, dry heaving, and anxiety in the past 2 weeks, and was hospitalized last week for their symptoms.It was noted that there were no traumas/events reported.No further complications were reported/anticipated.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from a consumer.It was reported that the patient¿s neurologist concluded that the patient¿s condition was probably caused by a medication whose side effects were all that the patient was going through ¿ nausea, vomiting, confusion, etc.The patient¿s doctors decided the patient should discontinue taking oxybutynin and reduce the dosage and frequency of ropinirole and reduce the use of lorazepam for the same reasons.It was noted that the patient was presently symptom free.No further complications were reported/anticipated.
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Search Alerts/Recalls
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