MAUDE Adverse Event Report: ABBOTT ASSURITY MRI; Implantable pulse generator, pacemaker (non-CRT)

Model Number PM2272

Device Problems Pacing Asynchronously (1441); Use of Device Problem (1670)

Patient Problems Arrhythmia (1721); Syncope/Fainting (4411)

Event Date 02/29/2024

Event Type  Injury  

Event Description

During an mri scan, the patient experienced arrhythmia and syncope.The physician suspected functional loss of capture occurred due to the programming of the device.Mri settings were enabled on the device prior to the mri scan.Session records of the event were unavailable as the device does not record events while in mri mode.The arrhythmia was successfully terminated via external defibrillation.The mri settings were again disabled and the device returned to programmed settings for the patient.The patient was in stable condition.

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• Brand Name: ASSURITY MRI
• Type of Device: Implantable pulse generator, pacemaker (non-CRT)
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 19003099
• MDR Text Key: 338895505
• Report Number: 2017865-2024-37160
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509589
• UDI-Public: 05414734509589
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P140033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: PM2272
• Device Lot Number: S000063166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2018
• 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: TENDRIL STS.; TENDRIL STS.
• Patient Outcome(s): Required Intervention