Model Number 3788 |
Device Problems
Device Inoperable (1663); Battery Problem (2885)
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Patient Problems
Discomfort (2330); Inadequate Pain Relief (2388)
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Event Date 09/24/2015 |
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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It was reported the patient experiences discomfort at the ipg site.The patient also reported the ipg was suddenly unable to communicate with external devices and the patient no longer has stimulation.Surgical intervention is planned 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 with a different model.Follow-up revealed the patient's issue is resolved.
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Search Alerts/Recalls
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