Model Number 3788 |
Device Problems
Nonstandard Device (1420); Device Inoperable (1663)
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Patient Problem
Inadequate Pain Relief (2388)
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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.
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Event Description
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It was reported the patient complained her scs system was not working.A sjm representative met with the patient and found the patient's ipg would not communicate with external devices.Surgical intervention is planned for 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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Follow-up identified the patient had her scs ipg replaced.Additional follow-up identified a sjm representative met with the patient to programed the patient's scs system and the reported issue has been resolved.
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Search Alerts/Recalls
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