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

Model Number PM2272

Device Problems Failure to Interrogate (1332); No Pacing (3268)

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

Event Date 12/15/2022

Event Type  Injury  

Event Description

During an in clinic follow-up, it was not possible to interrogate the device.An electrocardiogram (ecg) was performed and the device was no longer pacing the patient.A device exchange is planned.The patient was in stable condition.

Event Description

Additional information received indicated the event was resolved by explanting and replacing the device.The patient experienced no adverse consequences.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• 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: 16040952
• MDR Text Key: 306072767
• Report Number: 2017865-2022-50638
• Device Sequence Number: 1
• Product Code: LWP
• 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,Followup,Followup
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: PM2272
• Device Catalogue Number: PM2272
• Device Lot Number: P000094489
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2019
• 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