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

Model Number	3560022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Rash (2033); Local Reaction (2035); Urticaria (2278); Swelling/ Edema (4577)
Date of Event	04/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G2: country slovenia.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
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the trial patient started their trial on (b)(6) 2024.The patient has visited their abdominal surgeon for regular visit for checking the wounds and the wound management.After checking the patient's skin there was urticaria and initial systemic urticaria, and edema on parts of the skin where the extension was in direct contact.The doctor assume it could be an allergic reaction to the percutaneous extension materials.They did skin observation, anti-anaphylactic measures, and patient had been sent to or to immediate removal/explantation of the extension and was treated anti-anaphylactic.Further dermatology examinations are scheduled allergy tests to specific materials are scheduled. the patient is hemodynamic stabile all the time. they are awaiting to see if the patient is going to be suitable for permanent implantation of the permanent implantable neurostimulator (ins).The patient is ok and will be hospitalized until next week due to urticaria symptoms observation and potential permanent implantation.It is assumed that there is no need for product analyses that is why the extension is not going to be returned.The product has been sent to microbiological analysis.Additional information will be available on 2024-jul-02.Patient's medical history included fowler's syndrome and allergy to pollen.
Event or Problem Description
Additional information was received.The manufacturer representative (rep) further clarified that the patient has experienced urticaria due to the allergy on outern layers of the lead material.The allergy has been confirmed by dermatologist who performed the tests with the sample of the lead materials.Also additional test has been performed on the patient - a lead (model 978b133) has been put to the patients forearm to see if the patient is also allergic to the already implanted lead.After 5 days the patient developed urticaria.The lead has been explanted.Issue has been resolved.The patient is not suitable for therapy due to the confirmed allergic reaction to the material of the extension and the lead.
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
Continuation of d10: product id: 978b133, lot#: va2xhc5, product type: lead.Section d information references the main component of the system.Other relevant device(s) are: product id: model, serial/lot#: (b)(6), ubd: 2025-09-11, udi#: (b)(4).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.The manufacturer representative (rep) reported both products have been returned for analyses.The patient is completely explanted and is fine.The indication for use was fowler¿s syndrome.
Additional Manufacturer Narrative
The returned product 3560022, serial# (b)(6) and product 978b133, lot# va2xhc5 were subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.However, no analysis were performed due to the non-analyzable medical issue.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
H3: analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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
(b)(6) 2024 mpxr (b)(6), 4 images (rep, hcp, for): information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the trial patient started their trial on (b)(6) 2024.The patient has visited their abdominal surgeon for regular visit for checking the wounds and the wound management.After checking the patient's skin there was urticaria and initial systemic urticaria, and edema on parts of the skin where the extension was in direct contact.The doctor assume it could be an allergic reaction to the percutaneous extension materials.They did skin observation, anti-anaphylactic measures, and patient had been sent to or to immediate removal/explantation of the extension and was treated anti-anaphylactic.Further dermatology examinations are scheduled allergy tests to specific materials are scheduled.The patient is hemodynamic stabile all the time.They are awaiting to see if the patient is going to be suitable for permanent implantation of the permanent implantable neurostimulator (ins).The patient is ok and will be hospitalized until next week due to urticaria symptoms observation and potential permanent implantation.It is assumed that there is no need for product analyses that is why the extension is not going to be returned.The product has been sent to microbiological analysis.Additional information will be available on 2024-jul-02.Patient's medical history included fowler's syndrome and allergy to pollen.(b)(6) 2024 (b)(4) email x4 (for, rep): no new information 2024-jul-09 p300-253-2024 (b)(6), 3 reg inq (for, rep): no new information "[sent for urgent translation]" (b)(6) 2024 mpxr (b)(6), 2 images (for, rep): additional information was received.The manufacturer representative (rep) further clarified that the patient has experienced urticaria due to the allergy on outern layers of the lead material.The allergy has been confirmed by dermatologist who performed the tests with the sample of the lead materials.Also, additional test has been performed on the patient - a lead (model 978b133) has been put to the patients forearm to see if the patient is also allergic to the already implanted lead.After 5 days the patient developed urticaria.The lead has been explanted.Issue has been resolved.The patient is not suitable for therapy due to the confirmed allergic reaction to the material of the extension and the lead.2024-jul-19 e1, mpxr (b)(6), mpxr (b)(6) (for, rep): additional information was received.The manufacturer representative (rep) reported both products have been returned for analyses.The patient is completely explanted and is fine.The indication for use was fowler¿s syndrome.2024-jul-24 (b)(6) (for, rep): no new information.2024-jul-25 e3, (b)(6) (for, rep): no new information.

• Brand Name: INTERSTIM
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): Medtronic Puerto Rico Villalba; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; +1(763)526-5677
• MDR Report Key: 19646174
• Report Number: 2649622-2024-17332
• Device Sequence Number: 12408839
• Product Code: EZW
• UDI-Device Identifier: 00763000203894
• UDI-Public: (01)00763000203894(17)260122(10)VA2WG8E
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/03/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2026
• Device Model Number: 3560022
• Device Catalogue Number: 3560022
• Device Lot Number: VA2WG8E
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 07/04/2024; 07/04/2024; 07/19/2024; 07/25/2024; 07/31/2024; 05/22/2026; Not provided
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 07/12/2024; 07/18/2024; 07/24/2024; 07/30/2024; 08/09/2024; 08/18/2026; 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 121 LB