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

Model Number W1DR01

Device Problem Battery Problem (2885)

Patient Problem Exit Block (2628)

Event Date 09/11/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: etlw1610c124e stent, implanted: (b)(6) 2017; esbf2314c103e stent, implanted: (b)(6) 2017; etlw1620c93e, implanted: (b)(6) 2017; etlw1616c82e stent, implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced intermittent heart block.The right ventricular (rv) his bundle lead exhibited high thresholds and the implantable pulse generator (ipg) battery longevity had significantly decreased.The lead and ipg were explanted and replaced.The patient is a participant in the post approval clinical surveillance product surveillance registry.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Corrected: b5.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.

Event Description

It was reported that the patient experienced intermittent heart block.The right ventricular (rv) his bundle lead exhibited increasing thresholds and the implantable pulse generator (ipg) battery longevity had significantly decreased.The lead and ipg were explanted and replaced.The patient is a participant in the post approval clinical surveillance product surveillance registry.No 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 EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• MDR Report Key: 10183056
• MDR Text Key: 196058017
• Report Number: 9614453-2020-01910
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00643169871939
• UDI-Public: 00643169871939
• Combination Product (y/n): N
• PMA/PMN Number: P980035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/14/2020
• Device Model Number: W1DR01
• Device Catalogue Number: W1DR01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 06/23/2020
• Supplement Dates Manufacturer Received: 07/30/2020
• Supplement Dates FDA Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 383069 LEAD, 5076-52 LEAD; 383069 LEAD, 5076-52 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 81