Model Number PM3562 |
Device Problem
Under-Sensing (1661)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 10/16/2020 |
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 episodes of atrial undersensing was observed.Programming changes were suggested.No patient symptoms were reported.
|
|
Event Description
|
New information notes that the patient presented to the clinic on (b)(6) 2020, and programming changes were made.The patient condition was stable.
|
|
Search Alerts/Recalls
|