Model Number NEU_ENS_STIMULATOR |
Device Problem
Contamination (1120)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/20/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that the lead got contaminated before being implanted and a new lead needed to be opened.No symptoms were reported.
|
|
Manufacturer Narrative
|
Section d references the main component of the system.Other medical products in use during the event include: brand name sensight; product id b3300542m serial: (b)(6) product type: 0200-lead; implant date ; explant date medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Manufacturer Narrative
|
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Event Description
|
Additional information received from the manufacturer¿s representative (rep) reported the cause of the contamination was due to a resident leaning too close to the device and contaminating it with their head.A new device was opened and implanted.
|
|
Search Alerts/Recalls
|