Model Number CD2377-36QC |
Device Problems
Environmental Compatibility Problem (2929); Inappropriate or Unexpected Reset (2959)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Session records were provided for review by technical services.Analysis of the session records indicated that the reset associated with use in an off-label mri environment event was sensed by the device, leading to the device operating in bvvi mode with high voltage therapy disabled.
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Event Description
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It was reported that following an mri scan, the device was found to be in back up vvi (bvvi) mode resulting in disabled high voltage therapy.The cause of the bvvi was found to be magnetic resonance imaging (mri) exposure without enabling the mri settings.Abbott technical support was contacted and the device was successfully reprogrammed to resolve the event.The patient was in stable condition.
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Search Alerts/Recalls
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