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

Model Number W3DR01

Device Problem Protective Measures Problem (3015)

Patient Problem Palpitations (2467)

Event Date 04/20/2020

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the device was not returned for analysis.However, performance data collected from the device was received and analyzed.Analysis of the device memory was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experiences palpitations every morning at the same time.It was noted this was likely due to the nightly atrial lead position check (alpc) feature of the implantable pulse generator (ipg).The ipg remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: AZURE S 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 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10027783
• MDR Text Key: 189981059
• Report Number: 9614453-2020-01409
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P980035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2020

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: 07/14/2020
• Device Model Number: W3DR01
• Device Catalogue Number: W3DR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2020
• Initial Date FDA Received: 05/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2019
• 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