Model Number 102096-67A |
Device Problem
Difficult to Remove (1528)
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Patient Problem
Discomfort (2330)
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Event Date 11/26/2020 |
Event Type
Injury
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Manufacturer Narrative
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The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
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Event Description
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On november 26th 2020, senseonics was made aware of an adverse event where the physician was unable to remove the sensor on the first attempt made.
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Manufacturer Narrative
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The sensor was successfully removed during the second removal attempt on (b)(6) 2021.The high rate of inability to remove sensor was addressed under (b)(4) which was closed per (b)(4).No further investigation was found necessary.D6b.Explanted date updated to (b)(6) 2021.H6.Investigation findings updated to 3221.H6.Investigation conclusions updated to 4311.
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Search Alerts/Recalls
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