MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	977D260
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id: neu_epiduralneedle, serial# unknown, product type accessory section d information references the main component of the system.Other relevant device(s) are: product id: neu_epiduralneedle, serial/lot #: unknown, g2: the country of origin is china.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 distributor regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that there was a test lead failure; the lead puncture needle was found to be bent during the operation.The bent needle was noticed when opening the packaging during the surgery.The lead kit was replaced to complete the operation the same day; the issue was resolved.
Additional Manufacturer Narrative
H3: analysis of the needle (product id neu_epiduralneedle lot# serial# unknown implanted: explanted: product type accessory) determined the cannula of the introducer was bent.The returned epidural needle included both the cannula and the stylet.The cannula was bent at 5.2 cm from the distal end, and the stylet was bent at 5.3 cm from the distal end.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: SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: 22722437
• Report Number: 2649622-2025-21277
• Device Sequence Number: 12981365
• Product Code: LGW
• UDI-Device Identifier: 00763000324315
• UDI-Public: (01)00763000324315(17)271211(10)VA2W6W3020
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: 977D260
• Device Catalogue Number: 977D260
• Device Lot Number: VA2W6W3020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• 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: Unknown