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

Model Number	B3400060M
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a stage ii implant procedure, impedance testing initially displayed normal values.However, a few minutes later, measurements showed more than 10,000 ohms on all combinations from contact 0.The lead and extension connection were disconnected and reconnected, and impedance values returned to normal.A subsequent test again showed >10,000 ohms on contact 0.After multiple disconnects and reconnections of the extension, the intermittent impedance issues persisted.The surgeon opted to replace the extension.Following the implantation of a new extension, impedance values were consistently normal across 15-20 tests.No environmental or external factors were identified as contributing to the issue.The issue was resolved, and no further information is available from the healthcare professional.
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
2025-aug-20 mpxr 1336145 (rep, hcp): it was reported that during a stage ii implant procedure, impedance testing initially displayed normal values.However, a few minutes later, measurements showed more than 10 ,000 ohms on all combinations from contact 0.The lead and extension connection were disconnected and reconnected, and impedance values returned to normal.A subsequent test again showed >10,000 ohms on contact 0.After multiple disconnects and reconnections of the extension, the intermittent impedance issues persisted.The surgeon opted to replace the extension.Following the implantation of a new extension, impedance values were consistently normal across 15-20 tests.No environmental or external factors were identified as contributing to the issue.The issue was resolved, and no further information is available from the healthcare professional.
Additional Manufacturer Narrative
The returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis identified that the extension was stretched; however electrical testing determined that continuity was complete and there were no electrical shorts between circuits.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.

• Brand Name: SENSIGHT
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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: 23034516
• Report Number: 2649622-2025-25263
• Device Sequence Number: 18505388
• Product Code: PJS
• UDI-Device Identifier: 00763000426484
• UDI-Public: (01)00763000426484(17)270614(10)VA34U6YV78
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 01/26/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: B3400060M
• Device Catalogue Number: B3400060M
• Device Lot Number: VA34U6YV78
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 09/30/2025; 01/26/2026
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/27/2025; 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female