Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2021
Event Type
malfunction
Manufacturer Narrative
This report is part of a retrospective review and remediation efforts in response to a warning letter.Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event Description
Medtronic received information that battery cap cracked/damaged occurred.There was no adverse impact or consequence reported as a result of this event.