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

Model Number W1DR01

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unauthorized Access to Computer System (3025)

Patient Problems Arrhythmia (1721); Chest Pain (1776); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Hypervolemia (2664)

Event Type  Injury  

Event Description

It was reported by the patient that their implantable pulse generator (ipg) was making their heart to palpitate rapidly/ felt arrhythmia even without any cardio activity on several occasions.It was also reported that the patient had a traumatice experience after the device placement where they were unable to breath and swallow water (dysphagia/ odynophagia).The patient suspected their device was being controlled by an outside force.The patient experienced chest pain and had excessive fluid retention in the body/ hypervolumia.The device remain in use.No further  patient complications have been reported as a result of this event.

Manufacturer Narrative

A voluntary medwatch form 3500 was received (report # mw5152665); since f10 is not contained on that form, select fields in section f have been populated by the manufacturer.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, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 19172446
• MDR Text Key: 340916420
• Report Number: 2182208-2024-01767
• Device Sequence Number: 1
• Product Code: NVZ
• 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,User Facility
• 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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: W1DR01
• Device Catalogue Number: W1DR01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/24/2024
• 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: 5076-52 LEAD, 5076-45 LEAD
• Patient Outcome(s): Other