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

Model Number W1DR01

Device Problems Unable to Obtain Readings (1516); Protective Measures Problem (3015)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: (b)(4) heart band implanted on (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there was a false alert for atrial impedance on the implantable pulse generator (ipg).The device remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated a false alert for lead impedance out of range.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AZURE XT DR MRI SURESCAN
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9259817
• MDR Text Key: 164736965
• Report Number: 9614453-2019-03683
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00643169871939
• UDI-Public: 00643169871939
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/26/2019

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: 03/14/2020
• Device Model Number: W1DR01
• Device Catalogue Number: W1DR01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: 11/02/2019
• Supplement Dates FDA Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2018
• 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
• Patient Age: 74 YR