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 Death (1802); Heart Failure (2206)

Event Date 08/23/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that 10 days post implant the patient died due to demised heart failure.

• 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: 10534575
• MDR Text Key: 206970844
• Report Number: 3004209178-2020-15936
• 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
• Report Date: 09/15/2020

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: 12/28/2021
• Device Model Number: W1DR01
• Device Catalogue Number: W1DR01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/15/2020
• Date Device Manufactured: 06/30/2020
• 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
• Treatment: 5076-58 LEAD, 5076-52 LEAD
• Patient Outcome(s): Death
• Patient Age: 83 YR