Model Number 97714 |
Device Problem
Electromagnetic Compatibility Problem (2927)
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Patient Problems
High Blood Pressure/ Hypertension (1908); Dizziness (2194); Palpitations (2467)
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Event Date 01/23/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.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 manufacturer's representative (rep) regarding an implantable neurostimulator (ins) for the treatment of spinal pain.It was reported that the patient was checking in at their managing physician's office using the kiosk when the suddenly got light headed, blood pressure rose and the patient's pulse and heart rate increased.The patient was sent to the er.Tech services stated that it was unlikely that the kiosk interacted and that the patient should be medically evaluated.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.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 manufacturer's representative (rep).The rep stated that the elevated heart rate, light headedness, and heightened blood pressure and pulse were related to their medication.The patient's primary doctor changed their dose and they feel better.
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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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Search Alerts/Recalls
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