MAUDE Adverse Event Report: ABBOTT ASSURITY MRI; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM2272

Device Problems Intermittent Capture (1080); Migration or Expulsion of Device (1395); Under-Sensing (1661); Device Sensing Problem (2917)

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

Event Date 11/01/2022

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2022-46038, 2017865-2022-46039.It was reported that intermittent capture, decreased r-wave sensing and varying pacing impedance were observed on the right ventricular (rv) channel.Additionally, decreased p-wave sensing, noise and oversensing were observed on the right atrial (ra) channel.The device was reprogrammed as an interim solution.An x-ray was performed and the device was found to have migrated from the original implanted location.A device revision procedure was performed, the device and rv lead were explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The event of failure to capture, sensing issue, and device migration was not confirmed.The device was received from the field with battery voltage above elective replacement level.Electrical and mechanical analysis performed indicated normal functionality.Additionally, visual inspection found no anomaly on the header related to the field concern.Further atrial, and ventricular capture test under nominal and field conditions indicated normal results.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 PACEMAKER PULSE GENERATOR
• 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: 15831999
• MDR Text Key: 303991067
• Report Number: 2017865-2022-46037
• 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
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: PM2272
• Device Catalogue Number: PM2272
• Device Lot Number: P000052217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2017
• 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