Model Number 3788 |
Device Problem
Use of Device Problem (1670)
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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).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.Udi(di): (b)(4).
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Event Description
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It was reported the patient did not charge the ipg as recommended.As a result the ipg was inoperable.An sjm representative confirmed the issue.Surgical intervention may be taken 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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It was reported the patient's ipg was explanted and replaced.The patient's therapy was restored which resolved the patient's issue.
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Search Alerts/Recalls
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