MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number NEU_INTERSTIM_INS

Device Problems Migration or Expulsion of Device (1395); Energy Output Problem (1431); Insufficient Information (3190)

Patient Problems Incontinence (1928); Scar Tissue (2060)

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id neu_unknown_lead lot# unknown.Product type lead section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_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

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 they got their new device in their opposite hip/upper buttock.There was no pain with this one but they were still having lead wire migration.This meant that sometimes it would be working well and then all of a sudden they would not be able to make it to a restroom in public.Now they have had 2 surgeries and look like a patchwork doll with three cuts across their lower back.They didn't know why they made a cut at the bottom of their spine when they did the replacement either, there was no explanation.Also, even with the "proper" doctor redoing this surgery, they still could not get anyone to call them back to help with issues that arose with the device and handheld remote.They had minimal relief.

Manufacturer Narrative

Continuation of d10: product id: neu_unknown_lead, lot# unknown, product type: lead; product id: neu_unknown, serial# unknown, product type: unknown.Upon further inspection, a correction was sent to update fda site id, mgf.Site id, and d3.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
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; ceiba norte industrial park; minneapolis,mn PR 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; ceiba norte industrial park; minneapolis,mn PR 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18680418
• MDR Text Key: 335078892
• Report Number: 3004209178-2024-04373
• Device Sequence Number: 1
• Product Code: EZW
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

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: NEU_INTERSTIM_INS
• Device Catalogue Number: NEU_INTERSTIM_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 02/09/2024
• Supplement Dates FDA Received: 02/09/2024
• 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...."