MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS AZURE XT DR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number W1DR01

Device Problem Insufficient Information (3190)

Patient Problem Atrial Fibrillation (1729)

Event Date 04/01/2024

Event Type  Injury  

Event Description

It was reported by the patient that the pacemaker got turned down and they are experiencing atrial fibrillation (af).The implantable pulse generator (ipg) remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Continuation of d10: w1dr01 ipg doi: (b)(6) 2021, etlw1610c156e stent graft doi: (b)(6) 2017, etlw1613c124e stent graft doi: (b)(6) 2017, esbf2514c103e stent graft doi: (b)(6) 2017.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
• Type of Device: 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 19171093
• MDR Text Key: 340897076
• Report Number: 3008973940-2024-02926
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00763000316846
• UDI-Public: 00763000316846
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2024

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/14/2023
• Device Model Number: W1DR01
• Device Catalogue Number: W1DR01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/24/2024
• Date Device Manufactured: 11/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 5076-45 LEAD, 5076-52 LEA
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male