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

Model Number 97800

Device Problems Failure to Interrogate (1332); Energy Output Problem (1431); Communication or Transmission Problem (2896); Electromagnetic Compatibility Problem (2927)

Patient Problems Incontinence (1928); Constipation (3274); Fecal Incontinence (4571); Insufficient Information (4580)

Event Type  malfunction  

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 patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction adn fecal incontinence.It was reported that  as soon as the patient was finished talking to patient services (ps) and healthcare it they lost connection to their settings again and hadn't been able to get connected again.The patient stated they'd tried everything the other day but it didn't work and they weren't able to increase the stimulation.The patient reported that they've been wearing a pad for urinating and that they couldn't have a bowel movement, but every time they would go, they would get feces on their butt and they would have to wipe it down all the time and that it made them mad.The patient stated they had been moving in different rooms because they also had a dbs external device that they always had to keep on so they eventually moved to different rooms and they still couldn't connect.Patient services offered to assist the patient in connecting and the patient stated "that's gonna be tough" but they began to tap into the interstim x mytherapy application and they stated the communicator had been plugged in initially but they unplugged it and saw the light go solid blue but the patient kept seeing "is communicator on? " patient services had the patient toggle the bluetooth off and back on but that did not resolve the issue.The patient was very difficult to understand but said they thought their dbs stimulator in their body (which was "about 15 away") and the external devices for it was "messing" with the communication.Patient services had the patient restart the handset and power off the communicator.The patient was then able to successfully pair the communicator after turning the external devices back on and going into the interstim x mytherapy application.The patient received 'device not responding' a few times but was then able to connect to see their settings.The therapy was on and the patient was able to increase the stimulation.They stated initially they felt "a little bit electrical pulses" in their butt but then stated they felt it where they "urinate" and confirmed that by "electrical pulses" they meant they were feeling the usual tingling of the stimulation and that it was in their bike-seat and comfortable.Patient services reviewed with the patient to try to conne ct the next time away from any potential electro-magnetic interference.The patient stated they would do so.Please understand, the patient was having difficulty navigating the external devices and they were difficult to understand so patient services did the best they could to document the reported information.

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

On (b)(6) 2023, information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel disfunction and fecal incontinence.It was reported that the device was implanted for bowel leakage, but for the last 4 days they have been experiencing a return of bowel leakage.Caller was encountering "device not responding".Consulted mobility to help resolve.Helped caller connect to implant and increase settings.Patient will maintain stimulation level and will continue to track symptoms.On (b)(6) 2023, they reported that they have another implanted device for cervical dystonia and was unsure if it interferes with their ins.Patient states they finally connected and adjusted.The issue was not yet resolved.On (b)(6) 2023, they reported that they have another implanted device for cervical dystonia but they plug their device somewhere else.By moving their dbs device it helped.They are going in to show hospital the 3 devices and the doctor can check.It was reported that the issue was resolved.Patient reports the cause of being unable to increase stimulation due to the dbs device.To resolve this they moved and connected the dbs device farther than the ins.The cause of the dbs interfering with communication was determined to be settings to low.Patient followed up with hcp.

Event Description

Additional information was received from the patient.The cause of the device not responding was not known.They tried recharging the programmer 2 times, and one yesterday 2023-dec-01.Stim adjustment the 2023-dec-01.They still have problem yesterday and today, they [illegible] urinating.

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.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTERSTIM X
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18085018
• MDR Text Key: 328613761
• Report Number: 3004209178-2023-19239
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000484668
• UDI-Public: 00763000484668
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2024

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 Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 11/22/2023; 12/15/2023
• Supplement Dates FDA Received: 12/13/2023; 01/08/2024
• Date Device Manufactured: 06/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 52 KG