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

Model Number	W1SR01
Medical Device Problem Code	Reset Problem (3019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: 5076-52 lead, (b)(6) 2018.Product event summary: the device was returned and analyzed.Analysis of the returned device was inconclusive.Hybrid analysis determined the serious memory error was caused by the device reverting to running back-up firmware (bubu mode).The device entered bubu mode on (b)(6) 2020 due to the cumulative power on reset (por) threshold being met.The explant date was (b)(6) 2019.No root cause for the pors was confirmed and no new pors were noted.No hybrid anomalies were identified.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the implantable pulse generator (ipg) returned to the manufacturer for analysis following replacement and tested out-of-specification.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis #(b)(4):(b)(6)/ wed (b)(6) 2021 07:39:41 gmt-0600 central standard time analysis summary for pe#: (b)(4) analysis transaction id#: (b)(4) model#: w1sr01, serial/lot#: (b)(6).Methodology and techniques: the actual product involved in the event was evaluated.Electrical tests were performed.Mechanical tests were performed.Visual analysis was performed.Summary of analysis performed: during analysis, the following tests were performed: device - final analysis, and device - preliminary analysis.Results of analysis: based on analysis, it was determined the product failed to meet a performance specification.Product disposition: the returned product was retained in storage after the analysis concluded according to storage guidelines the product may be stored off site.If requested, the product may be returned to the patient provided after analysis the product was in a condition that it could be returned to the patient.Analysis information -- (b)(6) 2020 07:54:09 cst pli# 10 product id# w1sr01 the device was returned and analyzed.Analysis of the returned device was inconclusive.Hybrid analysis determined the serious memory error was caused by the device reverting to running back-up firmware (bubu mode).The device entered bubu mode on (b)(6) 2020 due to the cumulative power on reset (por) threshold being met.The explant date was (b)(6) 2019.No root cause for the pors was confirmed and no new pors were noted.No hybrid anomalies were identified.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was further reported that patient experienced pain while raising arm and that this implantable pulse generator (ipg) was explanted and replaced due to an upgrade to a dual chamber ipg.

• Brand Name: AZURE XT SR MRI SURESCAN
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• MDR Report Key: 11419614
• Report Number: 9614453-2021-00892
• Device Sequence Number: 4611695
• Product Code: NVZ
• UDI-Device Identifier: 00643169871953
• UDI-Public: 00643169871953
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/28/2019
• Device Model Number: W1SR01
• Device Catalogue Number: W1SR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5076-45 LEAD
• Patient Age: 63 YR