MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA SURESCAN; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number	978B128
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2025
Type of Reportable Event	Malfunction
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that they had a lack of electrode connectivity.The initially implanted electrode did not offer connectivity and therefore did not connect with the test control during the procedure.No known cause.The electrode replacement while still in the room.Issue resolved.It was identified that there was no connectivity with the electrode and with that a new electrode was used that then it was possible to complete the procedure.The surgery occurred normally after the use of another electrode and everything went correctly, without harm to the patient.The electrode will not be returned or removed for analysis.

• Brand Name: SURESCAN
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC PUERTO RICO VILLALBA; 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 ; 7635265677
• MDR Report Key: 22682654
• Report Number: 2649622-2025-20987
• Device Sequence Number: 9664192
• Product Code: EZW
• UDI-Device Identifier: 00763000596910
• UDI-Public: (01)00763000596910(17)260827(10)VA32VDR
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2025

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 Expiration Date: 08/27/2026
• Device Model Number: 978B128
• Device Catalogue Number: 978B128
• Device Lot Number: VA32VDR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2025
• Initial Report FDA Received Date: 07/31/2025
• Date Device Manufactured: 01/28/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Female