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

Model Number	W1SR01
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	Muscle Stimulation (1412); Chest Pain (1776)
Date of Event	09/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient felt chest pain and it was likely extracardiac stimulation.The implantable pulse generator (ipg) was reprogrammed.The patient is a participant in the post approval clinical surveillance product surveillance registry.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient felt chest pain which was considered likely to be extracardiac stimulation.The implantable pulse generator (ipg) was reprogrammed.The patient is a participant in the post approval clinical surveillance product surveillance registry.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was further reported that the right ventricular (rv) lead resulted in the patient's symptoms.The rv lead remains in use.

• Brand Name: AZURE
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• MDR Report Key: 8623839
• Report Number: 9614453-2019-01634
• Device Sequence Number: 2354668
• Product Code: NVZ
• UDI-Device Identifier: 00643169871953
• UDI-Public: 00643169871953
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/28/2019
• Device Model Number: W1SR01
• Device Catalogue Number: W1SR01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 05/20/2019; 10/15/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 05/20/2019; 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 383069 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 95