Model Number 377177 |
Device Problems
Failure to Capture (1081); Low impedance (2285); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/05/2024 |
Event Type
malfunction
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Event Description
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Lead had inadequate sensing, no capture, and impedance less than 200 in post op recovery after implant.Patient was returned to ep lab and lead was successfully repositioned.No adverse patient events were reported.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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Lead was explanted and replaced due to dislodgement 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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