MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC LEAD; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P

Model Number MDT-LEAD

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

Patient Problems Pleural Effusion (2010); Cardiac Tamponade (2226); Ischemia Stroke (4418); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

It was reported that the patient underwent a lead extraction procedure to remove the left ventricular (lv) lead and right ventricular (rv) lead.The procedure resulted in a cardiac tamponade, which required a patch repair via an open thoracotomy and a blood transfusion.The patient was hospitalized for a week.Diagnostic tests were performed including x-rays, a transesophageal echocardiogram (tee) to diagnose the cardiac tamponade, and computerized tomography (ct) scans for stroke concerns.A chest x-ray was performed one day prior to discharge and showed persistent mild edema and a trace/small pleural effusion.That status of the leads is unknown and no further information was obtained.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

A voluntary medwatch form 3500 was received (report #mw5145692); since f10 is not contained on that form, select fields in section f have been populated by the manufacturer.F1 user facility: unknown f2 uf/importer report number: unknown f3 user facility name/address: unknown f4 contact person: unknown f5 phone number: unknown f6 date user facility became aware of the event: unknown f7 type of report: voluntary f8 date of this report: 26-jul-2023 f9 approximate age of device: unknown f10 event problem codes: unknown f11 report sent to fda: no f12 location where event occurred: unknown f13 report sent to manufacturer: yes f14 manufacturer name and address: mfr.Name: medtronic address: 8200 coral sea street ne city: mounds view state: mn zip: 55112.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 LEAD
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P
• 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: 17987382
• MDR Text Key: 326298035
• Report Number: 2182208-2023-03150
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MDT-LEAD
• Device Catalogue Number: MDT-LEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2023
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention