Model Number 3788 |
Device Problems
Nonstandard Device (1420); Temperature Problem (3022)
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Patient Problems
Burning Sensation (2146); Discomfort (2330)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).This ipg serial number was included in a field advisory.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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It was reported the patient experiences uncomfortable heating at the scs ipg pocket site while recharging.A replacement charging system did not resolve the issue.Surgical intervention will be taken at a later date to address the issue.
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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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Additional information received identified the patient's scs ipg was explanted and replaced with another model.Effective stimulation was restored with the surgical intervention.After further review it was determined this device & patient are the same as reported under 1627487-2015-03430.
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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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Additional information received identified the issue resolved with the newscs ipg.
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Search Alerts/Recalls
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