Model Number CD3367-40QC |
Device Problems
Over-Sensing (1438); Pacing Asynchronously (1441)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/05/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Further information was requested but not received.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
|
|
Event Description
|
It was reported that post-paced t-wave oversensing was noted on the device.No intervention has been conducted at this time.The patient was stable with no consequences.
|
|
Event Description
|
Additional information received from technical support indicating that the event of post-paced t-wave oversensing was caused by fusion beats.Moreover, the event was noted during an in-clinic follow up.
|
|
Manufacturer Narrative
|
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
|
|
Search Alerts/Recalls
|