MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. Advisa MRI SureScan; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	A2DR01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient felt the pacing and pulsing in their neck and it wakes them up at night.It was also reported that the right ventricular (rv) lead exhibited steadily increasing impedance resulting in high impedance causing them to be unable to have magnetic resonance imaging (mri) scan.Both the implantable pulse generator (ipg) and the rv lead remains in use. no further patient complications have been reported as a result of this event.It was further reported that the rv lead exhibited polarity switch.The rv lead was reprogrammed and the ipg was explanted and replaced.
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: Advisa MRI SureScan
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(763)526-9277
• MDR Report Key: 50688933
• Report Number: 3004209178-2026-15175
• Device Sequence Number: 20162512
• Product Code: NVZ
• UDI-Device Identifier: 00613994713650
• UDI-Public: (01)00613994713650(17)160114
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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 Expiration Date: 01/14/2016
• Device Model Number: A2DR01
• Device Catalogue Number: A2DR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 07/21/2014
• 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: 5086MRI52.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Male