MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. AZURE XT SR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number W1SR01

Device Problem Pacing Problem (1439)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: evolutr-26-us transcatheter valve, implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient is not feeling well and that their heart rate was lower then the programmed lower rate of the implantable pulse generator (ipg).Ipg remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: AZURE XT SR MRI SURESCAN
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10654443
• MDR Text Key: 210654332
• Report Number: 3004209178-2020-17586
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00643169634626
• UDI-Public: 00643169634626
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/09/2020

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: 12/28/2020
• Device Model Number: W1SR01
• Device Catalogue Number: W1SR01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/09/2020
• Date Device Manufactured: 07/10/2019
• 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
• Treatment: 383069 LEAD
• Patient Age: 87 YR