Model Number 3189 |
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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