MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA SENSIGHT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number	B3301542
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that leads and lead test cable were bent.They were not used.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: product id: b3301542 (b)(6); product type: 0200-lead; product id: b31040 (b)(6); product type: 0215-screening device; implant date: n/a; explant date: n/a.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: b3301542, serial# (b)(6), product type: lead.Product id: b31040, lot# 0 82n09225a, product type: screening device.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
On (b)(6) 2026 an x 8 (rep): no new information.
Additional Manufacturer Narrative
Continuation of d10: product id b3301542 lot# serial# (b)(6), product type lead.Product id n eu_stylet_acc, serial# unknown, product type accessory product id neu_stylet_acc, serial# unknown, product type accessory.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 received from rep indicating they were present at the procedure.Leads were opened and handled properly.The physician confirmed that leads were not straight on his back table while measuring the leads.
Additional Manufacturer Narrative
Continuation of d10: product id b3301542 lot# serial# (b)(6): product type lead product id b31040 lot# 082n09225a serial# unknown, product type screening device product id neu_stylet_acc lot# serial# unknown, product type accessory product id neu_stylet_acc lot# serial# unknown, product type accessory 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
The returned device (b3301542, s/n: (b)(6)) was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.The returned device passed all laboratory testing, with no anomalies identified.The distal end of the lead is within the specified tolerance of 0.005 inches with the stylet fully inserted.With the stylet withdrawn, the distal end conforms to the specified diameter of ø = 0.02" as per specification.However, a slight bend was observed along the body of the lead.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
H11.

• Brand Name: SENSIGHT
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 23634168
• Report Number: 2649622-2025-33039
• Device Sequence Number: 15775489
• Product Code: MHY
• UDI-Device Identifier: 00763000426439
• UDI-Public: (01)00763000426439(17)271104
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/13/2026

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: B3301542
• Device Catalogue Number: B3301542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 11/24/2025; 01/13/2026; 02/20/2026; 04/27/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 11/24/2025; 01/14/2026; 03/02/2026; 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2025
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."; "SEE H11...."; "SEE H11...."; "SEE H11...."; SEE H11...
• Patient Age: 76 YR
• Patient Sex: Male