Model Number 429553 |
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 02/15/2023 |
Event Type
malfunction
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Event Description
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This device was explanted due to eri, possibly from high threshold on the lv lead.No adverse patient events were reported.Should additional information become available, 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 returned and analyzed.The device memory demonstrated a normal device function while the device was implanted and in service.The inspection of the device memory revealed that an elevated current was used for anti-bradycardia pacing.This indicates that high output was programmed that resulted in a faster discharge of the battery.The bench test of the icd revealed that all therapy functions were available, especially the current used for anti-bradycardia pacing was normal.In conclusion, the device was fully functional.There was no indication of a device malfunction.Analysis of the device revealed a normal battery depletion.
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Search Alerts/Recalls
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