Model Number 3788 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Weight Changes (2607)
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Event Date 07/19/2015 |
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's ipg was unable to communicate with the charger, but was able to use the programmer.The physician felt the ipg is deeper and the patient had gained weight in the previous 4 months.The patient's ipg was explanted and replaced with a different model which resolved 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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It was reported the patient's system was explanted.
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Search Alerts/Recalls
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