Model Number 353101 |
Device Problems
Unintended Collision (1429); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Pain (1994); Numbness (2415)
|
Event Date 03/16/2024 |
Event Type
Injury
|
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
|
Information was received from a trial patient who was using an external neurostimulator (ens) for urgency frequency.It was reported that the patient's trial started on 2024-mar-15.It was reported that the patient reported they had pain.The issue is ongoing. additional information was received 03/17 indicating that the patient fell on their back last night and is now in an extreme amount of pain and is concerned something may have happened to the leads.Patient was going to call their provider.The patient added that they fell in the bathtub.Patient mentioned they were going to get pain medication at the hospital.On 03/19 patient mentioned that their leg fell asleep.The patient indicated on 03/20 that they were in the hospital.
|
|
Manufacturer Narrative
|
Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefor this event does not meet the reporting requirements stipulated in 21 cfr 803.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
|
This event is no longer a reportable event.Mdr decision corrected to not reportable.No additional supplemental mdrs are required unless additional information received makes the event reportable.Due to gch functionality, the complaint flag cannot be flipped to "no" as a regulatory report exists in this pe.
|
|
Search Alerts/Recalls
|