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

Model Number W1DR01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Extreme Exhaustion (1843); Muscle Weakness (1967); Nausea (1970); Loss of Vision (2139); Vomiting (2144); Dizziness (2194); Confusion/ Disorientation (2553); Balance Problems (4401); Syncope/Fainting (4411)

Event Date 08/27/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that since implant the patient has been experiencing dizziness, fatigue, nausea, loss of vision, loss of balance, confusion, weakness and vomiting.It was further reported that the patient passed out.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 DR 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: 12114945
• MDR Text Key: 263803526
• Report Number: 3004209178-2021-10359
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00643169634589
• UDI-Public: 00643169634589
• 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: Physician
• Type of Report: Initial
• Report Date: 07/05/2021

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: 06/14/2021
• Device Model Number: W1DR01
• Device Catalogue Number: W1DR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 07/05/2021
• Date Device Manufactured: 12/20/2019
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 75 YR