MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
|
Back to Search Results |
|
Model Number 97800 |
Device Problems
Electromagnetic Interference (1194); Loss of Data (2903)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/25/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Date is estimated; month and year are valid.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 urge incontinence and urinary /bowel dysfunction.It was reported that the last time they flew, they lost all of their settings that they had from their manufacturer representative (rep).The last time the patient flew was probably late december.Patient said that when they turned their therapy back on again it just went to some kind of default settings.Patient service specialist reviewed that the therapy needs to be turned off if they are going through the airport scanning system or they have the option to request a manual search.Patient was able to turn therapy off and back on and see their correct settings during the call.
|
|
Search Alerts/Recalls
|
|
|