MAUDE Adverse Event Report: ABBOTT ASSURITY MRI; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number PM2272

Device Problems Pacemaker Found in Back-Up Mode (1440); Inappropriate or Unexpected Reset (2959)

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

Event Date 11/27/2023

Event Type  Injury  

Event Description

It was reported that the device was found in backup mode.The device was explanted and replaced to resolve the event.The patient was stable and there were no adverse consequences.

Manufacturer Narrative

The reported event of device in backup mode was confirmed.The device was in backup mode upon receipt caused by unknown source.Visual inspection of the header found no anomaly related to the field concern.Electrical and mechanical analysis performed after reloading the device code indicated normal functionality.Further evaluation of the output parameters found no anomaly.The device was monitored with load for several days and no anomaly was noted.Despite extensive testing backup operation could not be reproduced and the cause of reset is undetermined.Longevity assessment was performed, and the device was in normal range of operation with appropriate remaining longevity.

• 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: 18312452
• MDR Text Key: 330296964
• Report Number: 2017865-2023-94587
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509589
• UDI-Public: 05414734509589
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: PM2272
• Device Lot Number: P000104062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 12/21/2023; 02/16/2024
• Supplement Dates FDA Received: 12/21/2023; 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2020
• 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): Required Intervention