Model Number CD3371-40QC |
Device Problem
Inappropriate or Unexpected Reset (2959)
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Patient Problem
Muscle Stimulation (1412)
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Event Type
malfunction
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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It was reported that the device went into back-up mode after an magnetic resonance imaging (mri) which resulted in the patient receiving phrenic nerve stimulation.Technical support was able to restore device settings to resolve the event.The patient was stable and will continue to be monitored.
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Event Description
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Additional information received indicated that tachy therapy was disabled when the device went into backup mode.
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Search Alerts/Recalls
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