Model Number 408719 |
Device Problems
Electromagnetic Interference (1194); 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 03/06/2022 |
Event Type
malfunction
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Event Description
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Home monitoring alert for impedance greater than 3000 ohms (b)(6) 2022 and (b)(6) 2022.Lead noise as well as some type of emi seen on recordings (b)(6) 2022.Patient will be brought in for evaluation.Lead remains implanted.
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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 capped due to fracture on (b)(6) 2024 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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