Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Skin Erosion (2075)
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Event Date 06/16/2020 |
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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Related manufacturer report number 3006705815-2020-02561.It was reported that the patient's leads eroded through the skin.In turn, surgical intervention may be pending to address the issue.
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Event Description
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Additional information received indicated that surgical intervention took place wherein the ipg and leads were explanted.
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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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