Model Number 3788 |
Device Problems
Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Discomfort (2330)
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Event Type
Injury
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Manufacturer Narrative
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This ipg serial number is included in a field advisory.(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 has been experiencing discomfort at the ipg site.As a result, the patient may undergo surgical intervention.
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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).
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Search Alerts/Recalls
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