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

Model Number W3DR01

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Palpitations (2467)

Event Date 05/10/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported by the patient that they had a low heart rate and they suspected their implantable pulse generator (ipg) was not working properly.Follow-up with the patient's physician indicated that the heart rate was unrelated to the ipg.During the call, it was reported that the patient experienced palpitations due to the auto capture settings on the ipg.The ipg was programmed off as a result.No further patient complications have been reported as a result of this event.

• Brand Name: AZURE
• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7574809
• MDR Text Key: 110268850
• Report Number: 3004209178-2018-12759
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00643169634602
• UDI-Public: 00643169634602
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2018

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/28/2019
• Device Model Number: W3DR01
• Device Catalogue Number: W3DR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 06/06/2018
• Date Device Manufactured: 01/12/2018
• 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, 407652 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR