Model Number 3662 |
Device Problems
Temperature Problem (3022); Insufficient Information (3190)
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Patient Problems
No Consequences Or Impact To Patient (2199); Discomfort (2330)
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Event Date 09/25/2019 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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Manufacturer report number 1627487-2019-11572.Manufacturer report number 1627487-2019-11573.It was reported that the patient is planning to have their system explanted.No additional information is available at this time.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.
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Event Description
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Additional information received identified that patient underwent surgical intervention in result of heating sensation at the ipg site.Issue has resolved.
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Search Alerts/Recalls
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