Model Number 1458Q/75 |
Device Problems
Difficult to Insert (1316); Failure to Advance (2524)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 08/06/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
This product is registered as a combination product.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 a guidewire bunched up during an implantation procedure.It was also noted that the left ventricular lead was unable to be maneuvered in the patient's vein.Lead was exchanged for a different one and the procedure was able to be successfully completed.Patient was stable after the event and had no consequences.
|
|
Manufacturer Narrative
|
Analysis was normal.No anomalies were found.
|
|
Search Alerts/Recalls
|