Model Number 1458Q/86 |
Device Problem
Difficult to Insert (1316)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/23/2020 |
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 the patient presented in clinic for a novel biventricular pacemaker system implant.During the procedure, it was noted that the guidewire failed to be inserted into the left ventricular (lv) lead and the lead could not be implanted.The procedure was completed using an alternate lv lead on (b)(6) 2020.The patient was stable.
|
|
Manufacturer Narrative
|
Analysis was normal.No anomalies were found.
|
|
Search Alerts/Recalls
|