MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC ICD; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Model Number MDT-ICD

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

Patient Problems Unspecified Infection (1930); Sepsis (2067); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/01/2023

Event Type  Death  

Event Description

Literature was reviewed regarding transvenous lead extraction in octogenarians.The authors described patients who underwent lead ex traction and replacement procedures; the indications for lead extractions were local and systemic infections, unknown lead malfunctions, and other unknown reasons.There were procedural complications which occurred; one patient experienced tricuspid damage with clinical signs of heart failure responsive to medical therapy and other patients experienced worsening tricuspid valve function treated conservatively, hematoma at the pocket which required drainage, pericardial effusion without need for evacuation, femoral vascular lesion with need for intervention, arteriovenous fistula with need for treatment, and bleeding with the need for a transfusion.Within thirty days of the procedure and during the follow up period, there were patient deaths; the causes of death were progressive congestive heart failure, progressive systemic infection, and non-cardiac causes.The status of the devices is unknown.No additional adverse patient effects or product performance issues were reported.

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.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 baseline gender/age characteristics is male/85 years old.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.Referenced article: outcomes of transvenous lead extraction in octogenarians using bidirectional rotational mechanical sheaths.Pacing and clinical electrophysiology.2023; 46:960¿968.Doi: 10.1111/pace.14696 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.

• Brand Name: MEDTRONIC ICD
• Type of Device: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• 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: 17930355
• MDR Text Key: 325604791
• Report Number: 2182208-2023-03000
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MDT-ICD
• Device Catalogue Number: MDT-ICD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2023
• 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 LEADS
• Patient Outcome(s): Death
• Patient Age: 85 YR
• Patient Sex: Male