Model Number G148 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/25/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) stated that their remote communicator displayed a red call doctor icon (rcd).The patient stated that red code doctor light was showing up for 10 hours and then went away.Subsequently, troubleshooting was performed, and the communicator was power cycled.The patient was referred to contact their clinic regarding the red call doctor icon.At this time, this device remains in service and there were no adverse patient effects reported.
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Manufacturer Narrative
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This report captures the explant of this device and impact on the patient.
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Event Description
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It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) stated that their remote communicator displayed a red call doctor icon (rcd).The patient stated that red code doctor light was showing up for 10 hours and then went away.Subsequently, troubleshooting was performed, and the communicator was power cycled.The patient was referred to contact their clinic regarding the red call doctor icon.At this time, this device remains in service and there were no adverse patient effects reported.Additional information received indicated that this device was explanted and successfully replaced.No additional patient adverse effects were reported.
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Search Alerts/Recalls
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