Model Number 3788 |
Device Problem
Unintended Movement (3026)
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Patient Problem
Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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Explant date: (the explant date was inadvertently omitted from the first follow-up report.) 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 has been experiencing pain at the ipg site due to the ipg being angled in the pocket.In turn, the ipg is having difficulty communicating with the charging system.As a result, the patient will undergo surgical intervention.
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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 (with a different model).The replacement ipg was implanted in a new location.
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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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