Model Number 3788 |
Device Problems
Failure to Charge (1085); Nonstandard Device (1420); Temperature Problem (3022)
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Patient Problems
Burning Sensation (2146); Discomfort (2330); Inadequate Pain Relief (2388)
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Event Type
Injury
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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.(b)(4).
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Event Description
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It was reported the patient is at stim off as he is unable to charge and has experienced uncomfortable pocket heating while charging (date of event is unknown).As a result, surgical intervention will be taken at a later date to address the issues.
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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.After further review it was determined this device & patient is the same as reported under 1627487-2015-03443.
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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 new scs ipg.
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Search Alerts/Recalls
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