MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA MRI XT DR SURESCAN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	DDMB1D1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Sepsis (2067)
Date of Event	01/12/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Concomitant medical products: product id 407652 ((b)(6)); product type: 0270-lead-lv-pace; implant date (b)(6) 2009; product id 694765 ((b)(6)); product type: 0264-lead-hv; implant date (b)(6) 2009;  medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that the patient developed shortness of breath and developed oropharyngeal bleeding.The patient was brought to the emergency department via ambulance.The patient was evaluated and treated for hypotension and possible sepsis with fluids, medications, and oxygen.Due to the patient's complex medical history including treatment for oropharyngeal cancer and consultation with medical care team the patient elected to pursue comfort care and passed away.The patient's cause of death was provided as severe hypotension likely due to blood loss anemia, diuretics, possible sepsis, and hypoxic respiratory failure.The patient is a participant in a clinical study.

• Brand Name: EVERA MRI XT DR SURESCAN
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 20219525
• Report Number: 3004209178-2024-18526
• Device Sequence Number: 8151962
• Product Code: LWS
• UDI-Device Identifier: 00643169929197
• UDI-Public: 00643169929197
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/28/2018
• Device Model Number: DDMB1D1
• Device Catalogue Number: DDMB1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 09/14/2024
• Date Device Manufactured: 06/09/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: SEE H11...
• Outcome Attributed to Adverse Event: Death
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Race: White