MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. AZURE XT SR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	W1SR01
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the remote monitoring mobile application generated a message indicating that it was searching for the patient connector when the connector was placed on the patient¿s chest.It was noted that bluetooth status on the connector appeared connected, with the power indicator solid green, the bluetooth indicator solid blue, and the status indicator blinking yellow.It was further noted that attempts to interrogate the implantable pulse generator (ipg) resulted in a ¿no device found¿ message. bluetooth on the implantable pulse generator (ipg) was confirmed to be active, indicated by a blue light.When attempting to locate the device, the connector blinked orange and displayed an ¿unable to find device¿ message.The connection attempt was unsuccessful despite the model being powered on and within range. troubleshooting steps were taken to include confirming bluetooth was enabled on the host tablet and that wireless fidelity was connected, power cycling the host tablet, and confirming both the host tablet and patient connector were connected to external power.The issue persisted following these steps. the implantable pulse generator (ipg) remains in use.No patient complications have been reported as a result of this event.

• Brand Name: AZURE XT SR 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 55112-4391 ; 7635269277
• MDR Report Key: 24175966
• Report Number: 3004209178-2026-01225
• Device Sequence Number: 9579026
• Product Code: NVZ
• UDI-Device Identifier: 00643169634626
• UDI-Public: (01)00643169634626(17)210128(10)RNA214123H
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/28/2021
• Device Model Number: W1SR01
• Device Catalogue Number: W1SR01
• Device Lot Number: RNA214123H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2025
• Initial Report FDA Received Date: 01/26/2026
• Date Device Manufactured: 08/01/2019
• 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: 407452 LEAD
• Patient Age: 77 YR
• Patient Sex: Male