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

Model Number	97810
Medical Device Problem Codes	Intermittent Continuity (1121); Electromagnetic Interference (1194); Overheating of Device (1437); Data Problem (3196)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction.It was reported that the reason for the call was the patient said they had a machine at work that was affecting their device.The patient said the machine was induction welding and they were 2 feet away from it and all of a sudden it changed.The patient also said it heated up and felt like an ant bit them inside where the electrodes are.The patient mentioned the device acted funny and affected the level of stimulation.The patient was on the other side of a concrete wall 2 meters away and could still feel the device heating up.The patient also said it was also causing the stimulation to turn on and off.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.Patient and employee were both on the call.
Additional 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.
Additional 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 or Problem Description
Additional information was received from a healthcare professional (hcp).The hcp reported that the cause of the device heating up had not been determined and what most likely cause or contributed to this issue that is unknown.The patient reported feeling warmth and heat at the site of their device when they were in close proximity to a specific type of machine that they used at work.They had this device for their bladder and bowel.When asked what steps were you were or will be taken to resolve this issue they reported that the patient came to them on 2025-dec-03 and they checked the device and they had normal impedance and they was feeling stimulation in the correct place they were not currently having pain as they were obviously nowhere near this machine that they used at their workplace.They did confirm that everything was working correctly on their device and the device itself had not been damaged but they had decided that it would best for the patient to work further from this machine and be asked or to ask for employers to move them to a different department or a different machine to use.When asked about the cause of the simulation changing turning on and off determined, they didn't the true cause of the stimulation change or the increase in simulation felt by the patient, but it did seem to correlate with being in close proximity to this machine that they used.

• Brand Name: INTERSTIM
• Common Device Name: 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 23743091
• Report Number: 3004209178-2025-20676
• Device Sequence Number: 21384716
• Product Code: EZW
• UDI-Device Identifier: 00763000596736
• UDI-Public: (01)00763000596736(17)260428
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2026
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 12/19/2025
• Date Device Manufactured: 11/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Unknown