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

Model Number PM2272

Device Problem Incorrect Measurement (1383)

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

Event Date 02/22/2024

Event Type  malfunction  

Event Description

Related manufacturer report number: 2017865-2024-34430.During an in-clinic follow-up, episodes of noise resulting in oversensing and inappropriate mode switch were observed on the atrial lead.Atrial lead damage was the suspected cause of the reported electrical anomalies.The device incorrectly interpreted these episodes as a loss of capture.No intervention was performed at this time.The patient was stable and will continue to be monitored.

Manufacturer Narrative

Further information was requested but not received.

Manufacturer Narrative

The reported event of false loss of capture (loc) during the presence of atrial noise was confirmed.Based on the information provided, the noise interfered with the ongoing beat to beat evoked response evaluation, resulting in the pseudo fusion criteria being met.The device entered fusion avoidance to confirm true loc, but the algorithm could not confirm capture and delivered a backup pulse due to the presence of noise.The device was performing per design.

• 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: 18866375
• MDR Text Key: 337235419
• Report Number: 2017865-2024-34429
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509589
• UDI-Public: 05414734509589
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: PM2272
• Device Lot Number: P000137027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2021
• 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