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

Model Number W1DR01

Device Problem Positioning Problem (3009)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 08/20/2021

Event Type  malfunction  

Event Description

It was reported by the patient that, post-operatively, they experienced neck pain and could feel their leads go under their collar bone.The patient reported pain and tenderness above their collar bone.Stabbing pain was reported from the back of the implantable pulse generator (ipg) and "from time to time the area around the device swells, on the edges and towards the arm pit".Patient complained their device moving around when they lay of the left side.The ipg system remains in use.No further patient complications have been reported as a result of this event.

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.

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 Description

It was further reported that that device check showed normal device function.It was further noted that the patient is quite thin and with ability to see the leads behind the device, but no risk of erosion.Patient was encouraged not to touch or manipulate the device site area.

• Brand Name: AZURE XT DR MRI SURESCAN
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 19086241
• MDR Text Key: 340573417
• Report Number: 9614453-2024-01435
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00643169871939
• UDI-Public: 00643169871939
• 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,Followup
• Report Date: 05/13/2024

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2023
• Device Model Number: W1DR01
• Device Catalogue Number: W1DR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/13/2024
• Date Device Manufactured: 07/23/2021
• 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: 5076-52 LEAD, 5076-45 LEAD
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 46 KG