MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO AZURE XT SR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number W1SR01

Device Problem Pacing Problem (1439)

Patient Problem Bradycardia (1751)

Event Date 12/09/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported one day post implant by the patient,  that they experienced low heart rates and the implantable pulse generator (ipg) was pacing below the programmed lower rate.The implantable pulse generator (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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 13122320
• MDR Text Key: 284871599
• Report Number: 3004209178-2021-19186
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00763000316709
• UDI-Public: 00763000316709
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/30/2021

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: 09/28/2013
• Device Model Number: W1SR01
• Device Catalogue Number: W1SR01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 12/30/2021
• Date Device Manufactured: 03/28/2012
• 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: 407645 LEAD
• Patient Age: 38 YR
• Patient Sex: Female