Model Number CD3369-40Q |
Device Problem
Over-Sensing (1438)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/29/2020 |
Event Type
malfunction
|
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.
|
|
Event Description
|
It was reported that the device exhibited post-paced t-wave over-sensing.Programming changes were made.The patient was in stable condition.
|
|
Event Description
|
New information received noted that the implantable cardioverter defibrillator exhibited more post-paced t-wave over-sensing episodes.Programming changes were made; the patient would continue to be monitored.The patient was in stable condition.
|
|
Search Alerts/Recalls
|