MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL AZURE S DR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	W3DR01
Medical Device Problem Code	Reset Problem (3019)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated an electrical reset.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that an internal review of data transmitted from the device indicated that a power on reset (por) occurred.The device remains in use.This event was not reported by a health care provider; therefore no patient complications were reported.
Additional Manufacturer Narrative
Concomitant medical products: 5076-45 lead implanted: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Corrected h6.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 S DR MRI SURESCAN
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 9088110
• Report Number: 9614453-2019-03136
• Device Sequence Number: 2323281
• Product Code: NVZ
• UDI-Device Identifier: 00643169871922
• UDI-Public: 00643169871922
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2025

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: 05/14/2019
• Device Model Number: W3DR01
• Device Catalogue Number: W3DR01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 08/23/2019; 04/03/2025
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 09/19/2019; 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2017
• 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.
• Patient Age: 79 YR
• Patient Sex: Male