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

Model Number MDT-ICD

Device Problems Electromagnetic Interference (1194); Electrical /Electronic Property Problem (1198); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 10/27/2021

Event Type  Injury  

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/56 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: cardiac mri based left ventricular global function index: association with disease severity in patients with icd for secondary prevention.Journal of clinical medicine.2021, 10, 4980.Doi: 10.3390/jcm10214980 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

A journal article was reviewed that contained information regarding the prognostic significance of left ventricular (lv) global function index (lvgfi) in patients with implantable cardioverter defibrillators (icd).The article reports patients who experienced inappropriate therapies which were defined as anti-tachycardia pacing (atp) or shock therapies in the case of a supraventricular arrhythmia (atrial fibrillation, atrial flutter, atrioventricular nodal reentry tachycardia (avnrt), atrioventricular reentrant tachycardia (avrt), sinus tachycardia, focal atrial tachycardia) or an oversensing due to lead issues or due to electromagnetic interferences.The status/disposition of the devices and leads is unknown.No further patient complications have been reported as a result of thisevent.

• 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: 15796725
• MDR Text Key: 303628292
• Report Number: 2182208-2022-03680
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 11/02/2022
• 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): Life Threatening
• Patient Age: 56 YR
• Patient Sex: Male