Model Number MN10450-50A |
Device Problem
Fracture (1260)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/15/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
The results/method and conclusion codes along with investigation results will be provided in the final report.Date of event is estimated.
|
|
Event Description
|
Related manufacturer reference number: 1627487-2021-00043.It was reported that, while adding 2 leads, the physician discovered that two of the patient's implanted leads were fractured.As a result, the patient's leads were explanted and replaced.
|
|
Manufacturer Narrative
|
The report event of fracture lead was confirmed.As received, visual inspection showed the returned lead (a) found a damaged on the outer tubing and all the internal lead wires being broken.These fractures are consistent with an overstress condition or sudden event the lead was subjected to while still in vivo.The cause of the event is consistent with damage during use.
|
|
Search Alerts/Recalls
|