Model Number 1458QL/86 |
Device Problems
Failure to Capture (1081); Insufficient Information (3190)
|
Patient Problems
No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/04/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
This product is registered as a combination product.The results/method and conclusion codes along with investigation results will be provided in the final report.
|
|
Event Description
|
It was reported that the patient presented for a lead revision procedure.The left ventricular lead was explanted and replaced for an unspecified reason.Patient condition was not reported.
|
|
Event Description
|
New information received notes the left ventricular lead was explanted and replaced for failure to capture.The patient was in stable condition.
|
|
Manufacturer Narrative
|
Analysis was normal.No anomalies were found.
|
|
Search Alerts/Recalls
|