Model Number 3383 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Skin Erosion (2075)
|
Event Date 11/05/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
The results/method and conclusion codes along with investigation results will be provided in subsequent submission.
|
|
Event Description
|
Related manufacturer reference number: 1627487-2019-13181, 1627487-2019-13182.It was reported that the patient had their system explanted due to lead erosion.
|
|
Manufacturer Narrative
|
The event of a full system explant was reported to abbott.The lead wire appeared to be very close to the surface of the skin.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.
|
|
Search Alerts/Recalls
|