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

Model Number MDT-CRT

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

Patient Problem Death (1802)

Event Date 07/26/2019

Event Type  Death  

Manufacturer Narrative

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 65 years old.The exact cause and date of death is not available at the time of this report; as there is no indication of specific serial number for patient information.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 lot/serial numbers.The model listed in the report is a representative of the model family, as there is no specific model listed.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: "association of remote monitoring with survival in heart failure patients undergoing cardiac resynchronization therapy: retrospective observational study." j med internet res 2019;21(7):e14142) doi: 10.2196/14142.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 association of remote monitoring with survival in heart failure patients undergoing cardiac resynchronization therapy.The article reports patient deaths of unknown causes.The status/disposition of the devices is unknown.Further follow up did not yet yield any additional information.

• 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: 10756006
• MDR Text Key: 213693468
• Report Number: 2182208-2020-02579
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: HU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 10/19/2020
• 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): Death
• Patient Age: 65 YR