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

Model Number	W1SR01
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2019
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 implantable pulse generator (ipg) setscrew came out of the device.It was further reported that the right ventricular (rv) lead exhibited high thresholds.The device and lead were explanted and replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: AZURE XT SR MRI SURESCAN
• 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: 8909449
• Report Number: 9614453-2019-02789
• Device Sequence Number: 205622
• Product Code: NVZ
• UDI-Device Identifier: 00643169871953
• UDI-Public: 00643169871953
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2019

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
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 08/29/2019; 09/06/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 09/06/2019; 09/09/2019
• 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: 5076-52 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR