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

Model Number 3058

Device Problems Display or Visual Feedback Problem (1184); Failure to Interrogate (1332); Inappropriate/Inadequate Shock/Stimulation (1574); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems Incontinence (1928); Pain (1994); Ambulation Difficulties (2544); Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 3889-28, lot#: va1f8px, implanted: (b)(6) 2017, explanted: (b)(6) 2022, product type lead, information references the main component of the system.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 06-mar-2021, udi#: (b)(4).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.It was reported that the patient had been having incontinence issues with their device, that they'd had it for 2 years and it never cleared up their incontinence and around the end of (b)(6) 2022, the patient all of sudden started feeling a lot of excruciating back pain, their "butt" (where their implant was) and down their leg.The patient stated they went to their managing health care provider (hcp) in (b)(6) 2022 where a manufacturing representative (rep) came in and tried to tweak it and changed the program and that didn't work so again in (b)(6) they met again with the rep and hcp again and they told the patient they got some lead error messages.The patient stated the message said "lead corruption," and that something was wrong with the leads and that it wouldn't connect to the program.The patient stated they told them "that's probably why i'm having this shocking" and they told the patient "oh no, that was just the program," and meanwhile the patient was experiencing this really bad back pain that was resonating into their hip and that they had been having trouble walking.The patient stated the hcp had the patient get an ultrasound that day to see if the leads had shifted and it was determined that they hadn't, that they were still where they needed to be however the device still would not go back on the normal programming they had been on initially.The patient stated that the rep had the patient turn the implant off for a week and a half and that within 48 hours, the patient had no pain.The patient stated they made the decision then to have the implant removed and the hcp told the patient they still had their sling and they could take medications.The patient stated they had the implant removed on (b)(6) 2022.The rep remembered the patient and their meeting.They met on (b)(6) 2022 at 2:15.The nurse did an impedance check and it did show high impedance, but it was cleared, so the rep indicated that there were no issues with the leads.The patient must have heard the nurse talking about the impedance results, which would explain the comments made by the patient.The rep indicated that they did not know about the surgery planned for the patient¿s device being removed until (b)(6) 2022.The rep did not think anything of the device removal at the time since the patient indicated that it was elective by stated that they wanted it to be removed so they could have an mri because of their back pain.The rep also stated they remember filling out an mpxr in relation to the lead complaints, but they cannot find it anywhere.Additional information was received from the rep.The nurse practitioner (np) had measured the values and they were 'high' and the np was unable to clear 2 of the values, so the rep then saw the patient and all values were 'clear' at that time.Rep did not see/was not informed as to whether values were high/normal or out of range high.She was only called in by the np to double check the high values, which were cleared through normal troubleshooting at the time.Rep never identified an issue with the lead, was informed the values were high, but did not observe any issue when they met with the patient.

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.

• 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: 15381274
• MDR Text Key: 299497747
• Report Number: 3004209178-2022-11510
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2023

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: 04/14/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/08/2022
• Supplement Dates Manufacturer Received: 10/24/2023
• Supplement Dates FDA Received: 11/15/2023
• Date Device Manufactured: 10/23/2018
• 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...."
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 88 KG