MAUDE Adverse Event Report: Medtronic Puerto Rico Villalba SelectSecure MRI SureScan; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV)

Model Number	383069
Medical Device Problem Codes	Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Under-Sensing (1661); Capturing Problem (2891); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); High Capture Threshold (3266); Unstable Capture Threshold (3269)
Health Effect - Clinical Codes	Bradycardia (1751); Dizziness (2194); Cardiac Perforation (2513); Asystole (4442)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately three weeks post implant of an implantable pulse generator (ipg) system, the patient experienced asystole, which seen from the ambulance electrocardiogram (ecg) recording when they were hooked up to an external pacer.The patient also experienced bradycardia, dizziness and pre-syncope.The right ventricular (rv) lead exhibited unstable thresholds, no capture, oversensing, short v-v intervals, cross talk oversensing, undersensing, high and rising thresholds and high impedance.A possible micro perforation was suspected and the lead had pulled back resulting in poor tissue interface.The rv lead was explanted and replaced.It was also noted that the right atrial (ra) lead exhibited cross talk oversensing.The lead remains in use. no further patient complications have been reported as a result of this event.
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: SelectSecure MRI SureScan
• Common Device Name: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV)
• 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: 50914834
• Report Number: 2649622-2026-28588
• Device Sequence Number: 5999032
• Product Code: NVN
• UDI-Device Identifier: 00763000740269
• UDI-Public: (01)00763000740269(17)280625(20)01
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: Lay User/Patient
• Device Model Number: 383069
• Device Catalogue Number: 383069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2026
• 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, W3DR01 IPG.
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 224 LB