Model Number 97800 |
Device Problems
Intermittent Continuity (1121); Failure to Deliver Energy (1211); Patient Device Interaction Problem (4001)
|
Patient Problems
Pain (1994); Urinary Frequency (2275)
|
Event Date 03/05/2024 |
Event Type
malfunction
|
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 patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that they don't feel anything.They were just peeing and changing their pads at least six times a day.If they do certain things or move certain ways they can feel the stimulation.Sometimes it is painful but not on the side where the device is on the right.Yesterday they had physical therapy for lower legs and afterwards it was getting painful on the left side where the lead is.It went away after a while.The issue started several days ago.Patient is on program 1 at 4.5 ma.On the call the patient changed the program to 2 at 3.8 ma.Patient will maintain stimulation level and will continue to track symptoms.Redirect to doctor if issue persists.
|
|
Event Description
|
Additional information was received from the patient.The cause of the stimulation issues were determined.They had to change the setting on their back and it was good to go.The issue was resolved.
|
|
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.
|
|
Search Alerts/Recalls
|