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

Model Number MDT-LEAD

Device Problems Fracture (1260); Inappropriate/Inadequate Shock/Stimulation (1574); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009); Device Handling Problem (3265)

Patient Problems Unspecified Infection (1930); Shock from Patient Lead(s) (3162)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.This event occurred outside the us.Patient information is limited due to confidentiality concerns.The overall baseline gender characteristics is male; the age of the patients was approximately 63 years old.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers.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: "strategies to reduce complications in complex device procedures such as icd and crtd implantation: a decade long contemporary single-centre experience." journal of arrhythmia.2019;35(suppl.1):328¿472.Doi: 10.1002/joa3.12273.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding strategies to reduce complications in complex device procedures such as implantable cardioverter defibrillator (icd) and cardiac resynchronization therapy defibrillator (crt-d).The article reported patients implanted with right ventricular (rv) leads using two specific procedural strategies employed which included routine use of cephalic vein access and positioning of the rv lead in a septal position.There were complications such as lead repositioning, lead fracture which required replacement, inappropriate therapy, phrenic nerve stimulation which forced abandonment of left ventricular pacing, cessation of anticoagulant and hospitalization, and infection requiring lead removal.The status/ disposition of the leads is unknown.No further patient complications have been reported as a result of this event.Further follow up did not yet yield any additional information.

Event Description

It was further reported that the fractures were related to only competitor leads.

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.

• Brand Name: MEDTRONIC LEAD
• Type of Device: PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 10681097
• MDR Text Key: 211431980
• Report Number: 2182208-2020-02376
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDT-LEAD
• Device Catalogue Number: MDT-LEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR