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

Model Number W1DR01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Congestive Heart Failure (1783); Death (1802); Sepsis (2067)

Event Date 12/27/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the patient with implantable pulse generator (ipg) system is deceased.The cause of death was determined as: cardiac arrest, sepsis, class 4 diastolic congestive heart failure.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.The device was returned and screening analysis was performed, but no issue was identified requiring full analysis.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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 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: 9606580
• MDR Text Key: 175632193
• Report Number: 3004209178-2020-01389
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2020

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/28/2019
• Device Model Number: W1DR01
• Device Catalogue Number: W1DR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 01/20/2020
• Supplement Dates Manufacturer Received: 01/21/2020; 03/13/2020
• Supplement Dates FDA Received: 02/06/2020; 03/16/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/11/2018
• 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 Outcome(s): Death
• Patient Age: 93 YR