MAUDE Adverse Event Report: Medtronic Puerto Rico Villalba CapSureFix Novus MRI SureScan; PERMANENT PACEMAKER ELECTRODE

Model Number	407658
Medical Device Problem Codes	Failure to Capture (1081); High Capture Threshold (3266)
Health Effect - Clinical Codes	Bradycardia (1751); Chest Pain (1776)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported approximately two weeks after implant that the patient experienced chest pain and bradycardia.The right ventricular (rv) lead exhibited no capture and high thresholds.The lead remains in use. no further patient complications have been reported as a result of this event.
Event or Problem Description
It was further reported that the rv lead was revised and remains in use.
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.
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: CapSureFix Novus MRI SureScan
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• 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: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(763)526-9277
• MDR Report Key: 50712625
• Report Number: 2649622-2026-26869
• Device Sequence Number: 9779071
• Product Code: DTB
• UDI-Device Identifier: 00643169708204
• UDI-Public: (01)00643169708204(17)271120
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P930039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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: Lay User/Patient
• Device Model Number: 407658
• Device Catalogue Number: 407658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/10/2026
• Supplement Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 02/21/2026
• 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: 407652 LEAD, W1DR01 IPG.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 164 LB