Model Number 4470 |
Device Problem
Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/06/2021 |
Event Type
Injury
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Event Description
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It was reported that the leads were reversed in the header of the device.Subsequently, the patient underwent a revision procedure and the leads were put in the correct configuration without any patient complications.The device and leads remain in service.No additional adverse patient effects were reported.
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Manufacturer Narrative
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This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.
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Event Description
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It was reported that the leads were reversed in the header of the device.Subsequently, the patient underwent a revision procedure and the leads were put in the correct configuration without any patient complications.The device and leads remain in service.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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