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

Model Number W1SR01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sepsis (2067)

Event Date 01/24/2023

Event Type  Death  

Event Description

It was reported that the patient was admitted to hospital for sepsis and a high n-terminal pro b-type natriuretic peptide value.The patient passed away.The patient is a participant in a clinical study.

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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: AZURE XT SR 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: 19114351
• MDR Text Key: 340222949
• Report Number: 3008973940-2024-02716
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00763000316709
• UDI-Public: 00763000316709
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2024

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: 01/14/2023
• Device Model Number: W1SR01
• Device Catalogue Number: W1SR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/16/2024
• Date Device Manufactured: 07/21/2021
• 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: 383069 LEAD
• Patient Outcome(s): Death
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 105 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White