MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
|
Back to Search Results |
|
Model Number 97800 |
Device Problems
Energy Output Problem (1431); Overheating of Device (1437); Patient Device Interaction Problem (4001)
|
Patient Problems
Pain (1994); Burning Sensation (2146)
|
Event Date 03/15/2023 |
Event Type
Injury
|
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
|
Information was received from a friend/family member regarding a patient (pt) who was implanted with an implantable neurostimulator (ins) for fecal incontinence and urinary dysfunction/sacral nerve stim.Caller said that yesterday patient experienced strong stimulation around 4am in the morning and pt was still in bed at the time.The caller spoke with a manufacturer representative (rep) about this issue.The rep directed patient to decrease the setting.They switched programs and decreased the setting.This morning patient felt the stimulation again however caller said that patient wasn't in bed was in the kitchen.Caller also said that patient is now feeling a burning sensation and pain at ins and the ins site hurts whenever patient sits or stands.When asked, caller stated no falls or trauma and that the last time they adjusted the setting was in january.Reviewed suggestion to either decrease setting, change programs or to turn stimulation off.Caller said that patient had stimulation off earlier today for 15 minutes and didn't notice a change.Reviewed suggestion to keep stimulation off longer if going to turn stimulation off.Patient to monitor and track what they notice regarding stimulation sensation, burning or pin.Patient was redirected to their managing healthcare provider (hcp) office to have implanted device checked.
|
|
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 manufacturer representative (rep).The rep reported that the cause of the burning sensation and pain at the ins site was not determined, and the cause is unknown.To resolve the issue, the hcp is going to remove the device.The issue has not been resolved, but further action will be taken.
|
|
Event Description
|
Additional information was received from a manufacturer representative (rep).The rep reported that the cause was unknown and device was removed on (b)(6) 2023.
|
|
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.
|
|
Search Alerts/Recalls
|
|
|