MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC CRT; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number MDT-CRT

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)

Patient Problems Unspecified Infection (1930); Pneumothorax (2012); Shock from Patient Lead(s) (3162); Pericardial Effusion (3271)

Event Date 01/01/2022

Event Type  Injury  

Event Description

A journal article was reviewed that contained information regarding cardiac resynchronization therapy (crt) in patients with heart failure.The article reports patients with complications such as pneumothorax, pericardial effusion, coronary sinus dissection, and pocket infection.There were patients that received inappropriate defibrillation because of atrial tachyarrhythmias.The status/disposition of the devices and 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/65 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: the efficacy and safety outcomes of cardiac resynchronization therapy in patients with heart failure in thailand: phramongkutklao experience.Journal of arrhythmia.2022;38:126¿136.Doi: 10.1002/joa3.12667.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MEDTRONIC CRT
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• 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: 14499515
• MDR Text Key: 292716859
• Report Number: 2182208-2022-01709
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDT-CRT
• Device Catalogue Number: MDT-CRT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• 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
• Treatment: UNKNOWN COMPETITOR LEADS
• Patient Outcome(s): Life Threatening
• Patient Age: 65 YR
• Patient Sex: Male