Model Number 1458Q/86 |
Device Problems
Failure to Capture (1081); Therapy Delivered to Incorrect Body Area (1508); Device Dislodged or Dislocated (2923)
|
Patient Problem
Undesired Nerve Stimulation (1980)
|
Event Date 07/20/2020 |
Event Type
Injury
|
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
|
During follow-up, loss of capture and phrenic nerve stimulation were observed on the left ventricular (lv) lead due to dislodgement.Revision surgery was anticipated.The patient was stable and there were no adverse consequences.
|
|
Event Description
|
It was reported that the left ventricular lead was explanted and replaced to resolve the event.The patient was stable following the procedure.
|
|
Search Alerts/Recalls
|