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

Model Number 3058

Device Problems Electromagnetic Interference (1194); Failure to Interrogate (1332); Energy Output Problem (1431); Ambient Noise Problem (2877); Communication or Transmission Problem (2896); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Discomfort (2330); Insufficient Information (4580)

Event Date 05/03/2023

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 (pt) who was implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor and urinary dysfunction/sacral nerve stim.It was reported that the ins seemed to "accelerate" after the dentist.Patient had increased stimulation (stim) the day before their dentist appointment.Patient had stim on during the dentist appointment.Patient said they thought they could leave stim on because the dentist was not using any drills.Patient said the dentist did use an ultra sonic probe.Patient said the book they have didn't say anything about ultrasonic probes.Patient said their whole back was hurting up to their neck and shoulders.Patient felt a slow tapping sensation which was constant.Patient turned stim off and thought it had improved.Patient thought right now they were feeling pain from it happening.Patient said it was better but not wonderful.Patient said going to the dr was not practical for them. patient called back and repeated same information.Patient did say they felt the tapping this morning and still had the horrible back pain.Patient said they did turn stimulation down earlier and the tapping was lesser however it was still there.They had turned the therapy off for about 20-30 minutes and said they didn't feel the tapping but did feel the back pain.Patient services reviewed option to leave stimulation off longer or to switch programs.Patient said would need assistance in changing programs so decided will keep stimulation off for a few hours and later this afternoon around 4pm will have another person who can assist and may call back to review how to switch programs.Patient to monitor symptoms.Patient was directed to contact managing healthcare provider (hcp) to report their symptoms. pt called back to get further assistance with switching programs.Pt did reiterate the issue they had a the dentist using diathermy.Pt services walked pt through how to switch programs so that stim was comfortable and felt in the bike seat area.Pt will leave stim here and monitor symptoms.The patient called back on 2023-may-05 and stated when they last spoke to pt services they had left the stimulation at 0.1.Pt stated they only had it on for 1.5 hours and then started noticing a buzzing when laying down.Pt stated it was uncomfortable so they wanted to know if that was the end of the program they were on.Pt services reviewed stim should be comfortable so pt may want to consider switching to a different program.Pt states they will try that and monitor things.

Event Description

Additional information was received from the patient.Pt called back and stated they have been through all the programs and are on their very last one, program 7.Pt states so far this seems to be doing well and hasn't woken up at night with a "marching band going on between her legs".Pt states they are concerned that they won't be able to shut it off if this does start to occur however.Pt states on (b)(6) 2023 this did happen and the only way they could get it to stop was by changing the program.Pt did verify that they had successfully slid the blue ball in the off position but was still feeling stim.Pt services reviewed possible residual stim or possible shift in device causing nerve issues.Pt services encouraged pt to follow up with doctor if this continues on the current program.Pt states they have a doctor's appointment next (b)(6).

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

The patient called back and repeated a lot of the same information in regards to what occurred after the dental cleaning.She said her leads are doing crazy things at night.Causing pain not just in the bicycle seat area.It goes down her leg and up her back toward her shoulder blade.Patient said she has been working with the doctor and the pa in switching programs.Patient wanted to know about mri.Helped her put her device in mri mode and she showed full body eligible.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received from the patient.Pt called back and stated they have been through all the programs and are on their very last one, program 7.Pt states so far this seems to be doing well and hasn't woken up at night with a "marching band going on between her legs".Pt states they are concerned that they won't be able to shut it off if this does start to occur however.Pt states on (b)(6) 2023 this did happen and the only way they could get it to stop was by changing the program.Pt did verify that they had successfully slid the blue ball in the off position but was still feeling stim.Pt services reviewed possible residual stim or possible shift in device causing nerve issues.Pt services encouraged pt to follow up with doctor if this continues on the current program.Pt states they have a doctor's appointment next (b)(6).(b)(6) 2024 (b)(4) (con): the patient called back today and notes that the issue has only gotten worse.The ins remains showing as off but she still feels like something is there and it is 'vibrating all night'.The caller states she spoke with their healthcare provider (hcp) and the hcp said to 'leave it in for a year' and it might be fine.The patient states she cannot sleep.The patient states that she told hcp around christmas that the system needs to come out but the office was closed until the first of the year.The patient called back on the 1st of the year and hcp was no longer practicing so now she is going back to another hcp and has an appointment on (b)(6).The caller stated briefly that she could not connect to her ins but during the call she did connect to ins and confirmed ins remains showing as off.Agent noted that caller should continue to try to work with doctor on the issue.

Manufacturer Narrative

Continuation of d10: product id neu_unknown lot# serial# unknown implanted: explanted: product type unknown 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
• 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: 16886880
• MDR Text Key: 314757710
• Report Number: 3004209178-2023-06094
• 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,Followup
• Report Date: 03/22/2024

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: 02/28/2023
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 07/10/2023; 01/10/2024; 02/28/2024
• Supplement Dates FDA Received: 08/03/2023; 02/01/2024; 03/22/2024
• Date Device Manufactured: 09/09/2021
• 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
• Treatment: "SEE H10...."; "SEE H10...."; "SEE H11...."
• Patient Age: 75 YR
• Patient Sex: Female