Model Number CDHFA500Q |
Device Problem
Failure to Interrogate (1332)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/26/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that a patient presented with loss of bluetooth telemetry noted on the patient's implantable cardioverter defibrillator.No intervention or adverse patient consequences were reported.
|
|
Event Description
|
It was reported that a patient presented remotely with loss of bluetooth telemetry noted on the patient's implantable cardioverter defibrillator.The patient was unable to send a remote transmission as a result.The patient was seen in clinic on (b)(6) 2024.The patient's device was interrogated, and bluetooth telemetry was noted to be enabled.Subsequent troubleshooting was performed, and a remote transmission was able to be sent.
|
|
Manufacturer Narrative
|
The results of the software analysis are inconclusive since relevant information related to the event was not able to be obtained.Based on the information received, the cause of the reported incident could not be conclusively determined.
|
|
Search Alerts/Recalls
|