MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL AZURE; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number W3DR01

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

Patient Problem Muscle Stimulation (1412)

Event Date 03/18/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient awakens nocturnally with a "twitch" and that this is associated with the atrial lead position check feature of the right atrial (ra) lead.It was reported that there was no malfunction on the right atrial (ra) lead and that the issue related to the ipg.The device remains in use and reprogramming is planned.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Upon secondary review it was determined that this event is not reportable.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AZURE
• 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: 8599785
• MDR Text Key: 144705615
• Report Number: 9614453-2019-01524
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P980035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

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 Expiration Date: 12/28/2019
• 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: 05/07/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 09/06/2019
• Supplement Dates FDA Received: 10/01/2019
• Date Device Manufactured: 07/09/2018
• 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: 4523 LEAD, 4023 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR