MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD. VERIFY; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number	3531
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Additional information was received.It was reported the steps for resolution was unknown.The lead was still in patient.
Event or Problem Description
Information was received from multiple sources (healthcare provider, distributor) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that trial patient had a lead failure clarifying that the lead broke.
Additional 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, serial/lot #: unknown, ubd: unknown, udi#: unknown.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.It was reported the steps were unknown.The lead will not be returned as it was still use.
Additional Manufacturer Narrative
Continuation of d10: product id 3889-28 lot# 0225447896: product type lead section d information references the main component of the system.Other relevant device(s) are: product id: model 3889-28, serial/lot #: 0225447896 , ubd: 2026-10-31, udi#: (b)(6).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.

• Brand Name: VERIFY
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD.; bayan lepas fiz, phase ii; bayan lepas,pin 11900 ; MY 11900
• Manufacturer (Section G): PLEXUS MANUFACTURING SDN. BHD.; bayan lepas fiz, phase ii; bayan lepas,pin 11900 ; MY 11900
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20881170
• Report Number: 3004593495-2024-00044
• Device Sequence Number: 18071471
• Product Code: EZW
• UDI-Device Identifier: 00643169725072
• UDI-Public: 00643169725072
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: 970004
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3531
• Device Catalogue Number: 3531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 12/11/2024; 01/07/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 12/18/2024; 01/14/2025
• Date Device Manufactured: 04/20/2022
• 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....".
• Patient Sex: Male