Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem
Bacterial Infection (1735)
Event Date 03/26/2022
Event Type
Injury
Event Description
It was reported that post lead implant, infection set in (serratia marcescence +).Per the healthcare professional, the leads were explanted on (b)(6) 2022. the issue was resolved at this time.
Manufacturer Narrative
Continuation of concomitant medical products: product id b32000, lot# 082m27121, implanted: (b)(6) 2022, explanted: (b)(6) 2022, product type: accessory p, ubd: 28-sep-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.