Model Number 459888 |
Device Problems
Intermittent Capture (1080); Failure to Capture (1081)
|
Patient Problem
Vomiting (2144)
|
Event Date 01/20/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that there was possible intermittent biventricular capture and the intermittent biventricular pacing appeared not to capture.It was further reported the patient was vomiting.The leads remain in use.No further patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Additional information received indicated the patient was admitted with hyperkalemia and in diabetic ketoacidosis.A device check was later performed and noted normal function.The loss of capture was suspected to be related to the patient's abnormal lab results.
|
|
Search Alerts/Recalls
|