Model Number CDHFA500Q |
Device Problems
No Apparent Adverse Event (3189); Interrogation Problem (4017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Further information was requested but not received.
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Event Description
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During remote monitoring, a bluetooth low energy (ble) telemetry anomaly on the device occurred resulting in an inability to be read by the remote monitoring application.The patient is anticipated to be seen in-clinic for further investigation, however, no intervention was performed at this time.The patient was stable and will continue to be monitored.
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Manufacturer Narrative
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Correction: upon review, the pulse generator should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction caused a serious event.
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Event Description
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Additional information received indicated the patient was later seen in-clinic, and ble telemetry was functioning normally.No device malfunction was suspected.
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Search Alerts/Recalls
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