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

Model Number W1DR01

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2024

Event Type  malfunction  

Event Description

It was reported that the during a generator change out when attempting to connect the right atrial (ra) lead to the replacement implantable pulse generator (ipg) no clicks were audible and the lead was easily pulled out of the header.The lead was taken out of the header, and the set screw was visually confirmed to not be obstructing the port.The lead was then re-inserted into the header while the wrench was held in place to vent any trapped air.Again, no wrench clicks were heard and the lead was not secured.The ipg was removed and replaced.When wrenching the ra lead into the replacement ipg wrench clicks were heard immediately and the lead was secured.A visible fracture was observed at the pin plug junction to the main lead body that had been suspected due to no capture of the atrial lead.The ipg was attempted not used, removed and replaced.The right atrial (ra) lead remains in use for sensing purposes.No 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.

• 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: 19173891
• MDR Text Key: 340945814
• Report Number: 3008973940-2024-02958
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W1DR01
• Device Catalogue Number: W1DR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2024
• Date Device Manufactured: 02/22/2024
• 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: "SEE H11...."
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 41 KG