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

Model Number	W3SR01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Syncope (1610)
Date of Event	08/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 310c31tissue valve, implanted: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient's spouse reported, the patient collapsed due to failed pacemaker, and was hospitalized for treatment.The ipg remains in use.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
Additional information received indicated the patient was upgraded to a bi-ventricular implantable cardioverter defibrillator (icd).The ipg was programmed off, and remains in the patient, out of service.No further patient complications have been reported as a result of this event.

• 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: 7907534
• Report Number: 9614453-2018-03327
• Device Sequence Number: 19203658
• Product Code: NVZ
• UDI-Device Identifier: 00643169871977
• UDI-Public: 00643169871977
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/28/2019
• Device Model Number: W3SR01
• Device Catalogue Number: W3SR01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 10/12/2018
• 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: 5071-53 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 62 YR