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

Model Number PM2272

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2024

Event Type  Injury  

Event Description

It was reported that the device was prophylactically explanted and replaced as it is subject to the zenex, assurity, endurity laser adhesion preparation field safety correction action which applies to a subset of devices distributed and implanted outside of the united states.No malfunction was reported, and the patient is in stable condition with no adverse consequences.

• 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: 19213634
• MDR Text Key: 341396610
• Report Number: 2017865-2024-40055
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509589
• UDI-Public: (01)05414734509589(10)P000139071(17)230731
• 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: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: PM2272
• Device Lot Number: P000139071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/11/2022
• 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
• Patient Outcome(s): Other