Model Number CDHFA500Q |
Device Problem
Failure to Interrogate (1332)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/25/2024 |
Event Type
malfunction
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Event Description
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It was reported that the implantable cardioverter defibrillator exhibited bluetooth telemetry loss.The patient was seen in clinic and the pairing was restored.There were no patient consequences reported.
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Manufacturer Narrative
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The reported event of device being unable to pair to the app was confirmed.Based on the information provided, the event was determined to be bluetooth (ble) lockout and the ble lockout occurred due to insufficient authorization.This is per device behavior as part of the cybersecurity feature; there is no malfunction suspected.No other anomalies were found.
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Event Description
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New information received notes that the implantable cardioverter defibrillator re-exhibited bluetooth telemetry loss.The patient was seen in clinic again and the pairing was restored.There were no patient consequences reported.
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Search Alerts/Recalls
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