Model Number 3788 |
Device Problems
Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Weight Changes (2607)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Recall numbers: 1627487-12192011-003-r.This ipg serial number was included in field advisories.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 experienced pain at the ipg site (date of event unknown).Reportedly, the patient has lost significant amount of weight.Subsequently, the ipg was explanted and replaced.
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Event Description
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Additional follow up identified the patient is no longer experiencing pain at the ipg site.The patient's issue has resolved through an ipg replacement.
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Search Alerts/Recalls
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