Model Number ENO DR |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/18/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.
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Event Description
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Another example of failed auto launch.I person check fine.Atrial post auto launch remains in unipolar and failed to swap to bipolar.Bipolar leads.
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Manufacturer Narrative
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Please refer to the attached analysis report.
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Event Description
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Another example of failed auto launch.I person check fine.Atrial post auto launch remains in unipolar and failed to swap to bipolar.Bipolar leads.
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Search Alerts/Recalls
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