MEDTRONIC NEUROMODULATION EXTERNAL NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
|
Back to Search Results |
|
Model Number NEU_ENS_STIMULATOR |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/25/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
Section d references the main component of the system.Other medical products in use during the event include: brand name stimloc; product id 924256 (lot: unknown); product type: 0001-accessory; 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.
|
|
Event Description
|
It was reported that the lead cap part was damaged.The cap was replaced and the issue was resolved.No symptoms were reported.
|
|
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 was received from the manufacturer representative (rep) that the cap was damaged out of the box.The cause of the damage was not determined.
|
|
Search Alerts/Recalls
|
|
|