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

Model Number PM1272

Device Problem Incorrect Measurement (1383)

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

Event Date 11/25/2022

Event Type  malfunction  

Event Description

It was reported, technical support was contacted due to the sense trend and pacing lead impedance trends that have stopped updating.Technical support recommended further investigation via in clinic follow up and reprogramming.No intervention has been performed at this time.The patient was stable and will continue being monitored.

Manufacturer Narrative

The reported event of sensing and pacing lead impedance (pli) measurements not occurring was confirmed.Based on the information provided, it was seen that the autocapture test was occurring at the same time as the sensing and pli measurements, this resulted in the sensing and pli measurements to be delayed and reattempted.The measurements were repeatedly postponed since the autocapture test was not successful due to a low pacing pulse, therefore the autocapture test and sensing/pli measurements both attempted to occur at the same time every hour.This is a result of a timing issue, and the device is performing as expected.

• 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: 16573493
• MDR Text Key: 311598142
• Report Number: 2017865-2023-14145
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509572
• UDI-Public: 05414734509572
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: PM1272
• Device Catalogue Number: PM1272
• Device Lot Number: P000060289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 03/20/2023
• Supplement Dates Manufacturer Received: 03/21/2023
• Supplement Dates FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2018
• 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