Model Number 408719 |
Device Problems
High impedance (1291); Ambient Noise Problem (2877)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/10/2022 |
Event Type
malfunction
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Event Description
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Out of range impedance measurements (greater than 3000 ohms) reportedly transmitted to home monitoring.Lv marker channel on transmitted recordings suggests oversensing of noise, and noise was reproducible in office with patient movement.Additional polarities to be tested.Lead 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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(b)(6) 2023 lead was capped 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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