MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL VISIA AF MRI XT VR SURESCAN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number DVFB1D4

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

Patient Problems Bacterial Infection (1735); Endocarditis (1834); Sepsis (2067)

Event Date 01/04/2023

Event Type  Death  

Manufacturer Narrative

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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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 Description

It was reported that the patient was deceased.It was noted that the patient had a transesophageal echocardiogram (tee) that revealed a large mobile mass of vegetation on the right atrial portion of the pacing lead.The patient was admitted with septic shock and was found to have methicillin-sensitive staphylococcus aureus bacteremia, and endocarditis and was immediately started on intravenous (iv) antibiotics.Due to persistent bacteremia, the patient underwent another tee and was noted to have new vegetations on the ventricular portion of the pacing lead.The physician noted it was unclear the duration of the bacteremia, however suspected the source to be from a skin boil resulting from an iv line from a recent hospitalization.The patient's implantable cardioverter defibrillator (icd) and rv lead were explanted and the patient was discharged from the hospital nine days later.It was reported that the patient had refused various medical interventions, care and testing while hospitalized and was discharged without a lifevest as not within the patients goals in their do not resuscitate (dnr).It was noted that the patient's septic shock had resolved and the patient was in a medically stable condition prior to discharge.The patient passed away nine days later.The patient was a participant in a clinical study.The disposition of the system is unknown and no autopsy was performed.

• Brand Name: VISIA AF MRI XT VR SURESCAN
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 16728023
• MDR Text Key: 313168710
• Report Number: 9614453-2023-01281
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00763000059507
• UDI-Public: 00763000059507
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2022
• Device Model Number: DVFB1D4
• Device Catalogue Number: DVFB1D4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2023
• Date Device Manufactured: 10/08/2020
• 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: 6947M55 LEAD.
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White