MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
|
Back to Search Results |
|
Model Number 97800 |
Device Problem
Loss of Data (2903)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/05/2023 |
Event Type
malfunction
|
Event Description
|
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urge incontinence and urinar y/bowel dysfunction.It was reported that they have been working with their manufacturer representative (rep) for the past 2- 3 weeks and they want to switch from program a to program b.Patient states they are on program a and they decided today they have done all they can with program a.Pt states they decided to switch to program b but they don't see that program available.Patient states today they noticed they are only seeing program 1-7 but no a and b.Pt states the rep put them on program a in the clinic.The issue was not resolved through troubleshooting.Rep contacted to see if they can assist the pt with finding the other two programs.
|
|
Manufacturer Narrative
|
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Additional information was received from a manufacture representative.The rep reported when asked to clarify patient not being able to find program a or b that patient had been working with the ins champion in the clinic.They believe patient didnt see program b due to patient not scrolling down all the way.Cause was unknown.The clinic has reached out to the patient to see if they were able to see program b but have not heard back from them.It is unknown if the issue is resolved.
|
|
Search Alerts/Recalls
|
|
|