MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Entrapment of Device (1212); Migration or Expulsion of Device (1395); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Patient Device Interaction Problem (4001)

Patient Problems Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Therapeutic Effects, Unexpected (2099); Discomfort (2330); Sleep Dysfunction (2517); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2017

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 3889-28, lot# va1exbn, implanted: (b)(6) 2017, product type: lead.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 22-feb-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) gastrointestinal/pelvic floor.It was reported the patient said they feel most of their stimulation in their right buttocks and down their leg.The patient said when they are trying to sleep on their right side, they feel extraordinary stimulation in their right buttock.The patient said that the sensation is so strong they can¿t sleep and have to position themselves further over on their right hip in order to minimize the stimulation.The patient said this was upsetting their sleep pattern.The patient wanted to know if their experience was appropriate and if they should be experiencing frontal pelvic area sensation.Additional information was receive on 2020-05-27, the patient confirmed that it is not uncomfortable.The patient has had the stimulation off for about a week to see if it made a difference.The patient also stated that they think they had better relief in the past when they had felt it in the scrotum area.The patient stated that the leads may have moved as well.No further complications noted or anticipated.

Manufacturer Narrative

Continuation of d11: product id 3889-28 lot# va1exbn serial# implanted: (b)(6) explanted: product type lead 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 consumer.It was reported that the cause of the lead migration is still unknown.The patient said the x-ray was taken this week which showed there was a lead migration.The patient said the lead is more into the pelvic area.No further patient complications are anticipated or expected as a result of this event.On (b)(6), the patient reported that there were nothing particular in the change of activities, as long as he can remember, higher stimulation, greater intensity especially troublesome when trying to sleep.X-ray indicated lead wire has migrated into pelvic area.Doctor turned down intensity.Lead have further discussion via zoom for next week.The patient lowered the setting to helped reduced uncomfortable feeling.Too early to tell about implant on voiding.The stimulation in the buttock were too intense to sleep, had to roll further onto the hip.The patient roll all the way over onto the hip, then they did not feel it so much in the buttock.They lowered the settings from 3.7 to 2.9, slept on the left side.Will have another procedure to correct and change to recharge the battery.No further patient complications are anticipated or expected as a result of this event.

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 received from the patient reported that they will discuss timetable to correct lead location and battery/device replacement during the next office visit in november.They reduced intensity on settings program 4 which helps sleep pattern with gradually increase over time.

Manufacturer Narrative

Continuation of d10: product id: 3889-28, lot#: va1exbn, implanted: on (b)(6) 2017, product type: lead, h6: due to imdrf harmonization, some previously submitted device, patient, method, result, and conclusion codes related to this event may have been updated.Correction: b2 and h1 should have previously been updated to 'intervention required' and 'serious injury' respectively.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.

Event Description

Additional information was received from the patient.They reported that the lead had been too far forward and was stimulating the sciatic nerve rather than the sacral.Information regarding mri eligibility if a component or fragment was left behind and concerns with full body scan without proper eligibility were reviewed.

Manufacturer Narrative

Continuation of d10: product id 3889-28 lot# va1exbn, implanted: (b)(6) 2017.Explanted: product type lead h6 has been updated.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 received from the patient.The patient stated that the device was replaced on (b)(6) 2021 and a portion of the lead was embedded in the tissue so the decision was made to leave it in place.No further actions are considered at this time.

Manufacturer Narrative

Continuation of d10: product id 3889-28 lot# va1exbn serial# implanted: (b)(6) 2017 product type lead.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.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10133030
• MDR Text Key: 194532858
• Report Number: 3004209178-2020-09956
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/16/2020
• Initial Date FDA Received: 06/09/2020
• Supplement Dates Manufacturer Received: 06/18/2020; 07/22/2020; 01/27/2021; 03/25/2021; 04/14/2021
• Supplement Dates FDA Received: 06/24/2020; 07/24/2020; 01/29/2021; 04/09/2021; 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 100