Model Number 3716 |
Device Problem
No Device Output (1435)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 10/05/2015 |
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 was unable to charge the ipg as she lost her charger a while ago.As a result, the ipg is currently inoperable.Surgical intervention will take place 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 surgical intervention was undertaken to explant and replace the patient's ipg.
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Search Alerts/Recalls
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