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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Pocket Stimulation (1463); Insufficient Information (3190)

Patient Problems Incontinence (1928); Device Overstimulation of Tissue (1991); Pain (1994); Dizziness (2194); Constipation (3274); Insufficient Information (4580)

Event Date 10/24/2023

Event Type  malfunction  

Manufacturer Narrative

B3: date is estimated; month and year are valid.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 dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that patient states they went 8- 9 months without having a bowel movement in their depends and then about a week ago they started having one again.Patient states wherever they have the device set at, it's not working.Patient services had patient attempt to communicate with implant but the handset would not power on.Patient will charge handset and will call back for assistance making an adjustment. patient called back in regards to this case, as they'd charged their external equipment and wanted assistance changing programs.Helped patient changed programs and patient increased stim to a comfortable level.Patient said they could feel stim on the "part of the tush that's part of the crack".When agent was reviewing general therapy expectations and guidelines, patient said "i'm doing something wrong here" and said they had to call back.Additional i nformation was received, caller indicates that they were having problems with accidents and yesterday they changed the settings and now they are feeling lightheaded.The caller asked if that could be related to the therapy.Reviewed with the caller that they could try turning the therapy back down to see if that resolves the lightheadedness.Additional information was received, patient reported they were having trouble with the stimulator and clarified that by "trouble" they meant that it hadn't been helping their symptoms.The patient stated they'd been fine for months and then a few days ago, all of a sudden the troubles began.The patient at the time of the call had switched from program 5 to program 6 and was increasing the stimulation.The patient was up to 5.6 v but they weren't feeling the stimulation.Patient services reviewed stimulation considerations with the patient and the patient then opted to switch back to program 5 again and increased the stimulation.The patient then stated they felt something going on with their stimulator in their back and they felt the stimulation briefly to the left of the implant but it went away and they only felt it in their bike-seat region.Patient services reviewed with the patient that they should only be feeling the stimulation in their bike-seat region and redirected the patient to follow up with their hcp about the issue if it persisted.The patient was going to monitor their symptoms now that a change had been made, make an additional adjustment or call back for assistance if needed and reach out to their managing health care provider for further concerns about their symptoms.

Event Description

Additional information was received from the patient.They called back regarding their bowel symptoms.Patient stated when they go to the bathroom they do not get all their stool out.Reviewed therapy adjustment options with patient.Patient will adjust therapy as needed and continue to monitor symptoms.They called back again on (b)(6) 2023 reporting a continuation of symptoms, stating they were still having accidents.Patient said they were having stimulation pain and tried to connect to their ins but couldn't because they were placing the wrong side of the communicator over their ins.Patient said their amplitude "wasn't set properly" because they didn't have the blue side of the communicator over their implant.On the call, patient connected to their ins and decreased stim to where the pain went away.Patient said now it was set properly so they would monitor symptoms.The patient called back again on (b)(6) 2023 and repeated therapy issues.They said that they were having trouble finding numbers that work and had gotten nowhere.Reviewed therapy information and general programming guidance.Patient did switch programs however said that having to be making adjustments was just too complicated.Patient also mentioned that the stimulator hurt when they sit down and after asking patient clarified that it wasn't the stimulation that hurt rather the neurostimulator itself hurt when patient sits on it and it doesn't hurt when they weren't sitting on it.Patient was redirected to their managing physician to access and address the situation.Patient said they have notified their managing physician.

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 the patient.The patient called back and mentioned they had bowel problems.When asked, pt could not confirm that the therapy was helping them by 50% or better since they said they don't know since they haven't used it in a while.The agent reviewed the communicator's general use with the patient.

• Brand Name: INTERSTIM II
• 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: 18058741
• MDR Text Key: 327212370
• Report Number: 3004209178-2023-18931
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000449711
• UDI-Public: 00763000449711
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2024

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 Expiration Date: 04/28/2023
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 11/22/2023; 01/23/2024
• Supplement Dates FDA Received: 12/12/2023; 02/12/2024
• Date Device Manufactured: 11/09/2021
• 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 Age: 74 YR
• Patient Sex: Female