Model Number 3662 |
Device Problem
Temperature Problem (3022)
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Patient Problem
Irritation (1941)
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Event Date 08/20/2020 |
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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It was reported the patient is experiencing heating sensation and irritation in the hip.This is due to the lower part of the battery being very close to the surface of the skin.As a result, the patient may undergo surgical intervention to address the issue.
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Event Description
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Additional information indicates the physician revised the ipg and created a new pocket on (b)(6) 2020.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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