Model Number 3788 |
Device Problems
Nonstandard Device (1420); Charging Problem (2892)
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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.(b)(4).
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Event Description
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It was reported the patient is unable to recharge her ipg.Subsequently, the patient may undergo surgical intervention as the next course of action.Please note: no additional information is known at this time.
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Event Description
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Follow-up information revealed the patient underwent surgical intervention where the ipg was explanted and replaced with a different model.Effective stimulation coverage was present post-op.Surgical intervention resolved the reported issue.
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Search Alerts/Recalls
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