Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Respiratory Distress (2045)
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Event Date 09/26/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.(b)(4).
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Event Description
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The patient's spouse reported the patient experienced difficulty in breathing in addition to upper abdominal pain.The patient was admitted to the hospital and stimulation was turned off.Ct scan and abdominal diagnostics tests were negative.Per the physician, the symptoms are related to positioning at the operating table and are unrelated to the scs system.The patient was reportedly discharged from the hospital.
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Manufacturer Narrative
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Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
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Event Description
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Follow-up identified the patient's pain issue has resolved upon restoring stimulation.
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Search Alerts/Recalls
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