MAUDE Adverse Event Report: MEDTRONIC FABRICATION S.A.S. TEMPORARY TRANSVENOUS PACING LEAD SYSTEM; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 6416-200

Device Problem Capturing Problem (2891)

Patient Problems Chest Pain (1776); Unspecified Infection (1930); Device Overstimulation of Tissue (1991); Thrombosis/Thrombus (4440); Pericarditis (4448)

Event Date 07/28/2010

Event Type  Injury  

Event Description

A journal article was reviewed that contained information regarding the incidence of venous thrombosis with temporary active-fixation lead implantation.The article reports three patients who were diagnosed via ultrasound with deep vein thrombosis (dvt) in the leg used for lead implantation.None of them showed external signs or symptoms of dvt.There were patients who experienced local infection at the lead insertion point and were treated conservatively.Three patients' leads had threshold increases that resolved with an increase in generator output.Two leads had to be replaced: one for muscle stimulation in the quadriceps and another for involuntary removal by a disoriented patient.Another patient had persistent post-implantation chest pain that was attributed to pericarditis (with minimal apical effusion on ultrasound) rather than lead perforation; this was resolved with anti-inflammatory treatment.The status/disposition of the leads is unknown.No further patient complications have been reported as a result of this event.

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/71 years old.The model listed in the report is a representative of the model family, as there is no specific model listed.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: lower incidence of venous thrombosis with temporary active-fixation lead implantation in mobile patients.Europace (2010) 12, 1604¿1607.Doi:10.1093/europace/euq262 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: TEMPORARY TRANSVENOUS PACING LEAD SYSTEM
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): MEDTRONIC FABRICATION S.A.S.; 103 route d anor; fourmies nord 59610 ; FR 59610
• Manufacturer (Section G): MEDTRONIC FABRICATION S.A.S.; 103 route d anor; fourmies nord 59610 ; FR 59610
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 15555586
• MDR Text Key: 301344330
• Report Number: 9611350-2022-00010
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K973360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6416-200
• Device Catalogue Number: 6416-200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2022
• 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; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male