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Model Number 3788 |
Device Problem
Temperature Problem (3022)
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Patient Problems
Burning Sensation (2146); Discomfort (2330)
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Event Date 03/17/2013 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.During processing of this complaint, attempts were made to obtain complete event information, but it could not be obtained.
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Event Description
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It was reported that the patient experienced pocket heating and discomfort.As a result, surgery occurred to explant the ipg on an unknown date to address the issue.
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Search Alerts/Recalls
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