Model Number 404633 |
Device Problem
Premature Elective Replacement Indicator (1483)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/25/2023 |
Event Type
malfunction
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Event Description
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Device is at eri indication with unexpected battery behavior.No adverse patient events were reported.Device currently remains implanted.Should additional information be received, this file will be updated.
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Manufacturer Narrative
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The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.
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Manufacturer Narrative
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The device was explanted on (b)(6) 2023.The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.
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Search Alerts/Recalls
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