Model Number 401183 |
Device Problems
Pacing Problem (1439); Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/29/2022 |
Event Type
malfunction
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Event Description
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Lead dislodged causing reduced biventricular pacing.The pulse generator was reprogrammed to vvi 40 back-up mode.The lead remains implanted with plan to revise soon.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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This lead 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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