MAUDE Adverse Event Report: Medtronic Singapore Operations Azure XT DR MRI SureScan; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	W1DR01
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Numbness (2415)
Date of Event	08/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the patient that, "i flagged my bedside machine, i was having atrial fibrillation (af) and had my bag packed to go to the emergency room when i pressed the button.I was having numbness in my head and feeling off.My doctor never called be back, when i asked they said they did not receive anything.Can we please check that?".The implantable pulse generator (ipg) remains in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10:  978b128 urinary stim lead implanted (b)(6) 2024; 97800 urinary stim ipg implanted (b)(6) 2024.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: Azure XT DR MRI SureScan
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): Medtronic Singapore Operations; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SN 486056
• Manufacturer (Section G): Medtronic Singapore Operations; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SN 486056
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(763)526-9277
• MDR Report Key: 50945536
• Report Number: 3008973940-2026-07299
• Device Sequence Number: 13373534
• Product Code: NVZ
• UDI-Device Identifier: 00763000316846
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: W1DR01
• Device Catalogue Number: W1DR01
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 09/30/2025
• 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: 5076-52 LEAD, W1DR01 IPG
• Patient Age: 79 YR
• Patient Sex: Female