MAUDE Adverse Event Report: MEDTRONIC, INC. SPRINT FIDELIS; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 6949

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

Patient Problems Endocarditis (1834); Heart Failure/Congestive Heart Failure (4446)

Event Date 12/22/2022

Event Type  Death  

Manufacturer Narrative

This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred outside the us.Patient information is limited due to confidentiality concerns.Patient age, gender, or weight cannot be provided due to regional privacy regulations.Of note, multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique product serial/lot numbers.The model listed in the report is a representative of the model family, as there is no specific model listed.The date of death is not available at the time of this report as there is no indication of specific serial number/patient information.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: incidence and clinical predictors of early and late complications of implantable cardioverter-defibrillators in adults with congenital heart disease.Canadian journal of cardiology.2023; 39, 236-245.Pmid: 36565849 doi: 10.1016/j.Cjca.2022.12.012 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

Literature was reviewed regarding early and late complications with implantable cardioverter defibrillators (icds) in patients with congenital heart disease.Complications were classified as early if they occurred up to three months after implantation or late if they occurred more than three months after.The authors described patient deaths; the causes of death were infective endocarditis (ie), progressive heart failure, and unknown causes.There is no allegation of device-death relatedness indicated in the article; however, the device-relatedness has been requested, but not yet received.Early complications noted were postprocedural hematomas that required hospital readmission, surgical evacuation, and treated with intravenous anticoagulant medication and lead dislodgements which required intervention.Late complications included inappropriate therapy, stroke, pocket infections, device-related infections, bloodstream infections with fever, neurologic pain, device erosion, perforation, and a dislodgement due to twiddler's syndrome.Infections were treated with antibiotics or underwent laser lead extraction.There were leads which exhibited increased impedance, noise, oversensing, crosstalk, failure to pace, and t-wave oversensing (twos) in which intervention was performed.The status of the devices and leads is unknown.No additional adverse patient effects or product performance issues were reported.

• Brand Name: SPRINT FIDELIS
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 16911747
• MDR Text Key: 315006766
• Report Number: 2182208-2023-01332
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P920015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 6949
• Device Catalogue Number: 6949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2023
• 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: UNKNOWN COMPETITOR ICD/CRTD.
• Patient Outcome(s): Death