Model Number 3788 |
Device Problem
Unintended Movement (3026)
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Patient Problem
No Code Available (3191)
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Event Date 01/21/2015 |
Event Type
Injury
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Event Description
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It was reported the patient's ipg is no longer secure in the pocket.As a result, the patient plans to undergo surgical intervention to address the issue.
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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.
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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 revealed the patient's ipg was explanted and replaced.
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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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Search Alerts/Recalls
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