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

Model Number PM2272

Device Problem Difficult to Remove (1528)

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

Event Date 08/22/2022

Event Type  Injury  

Event Description

It was reported that the device was explanted and replaced prophylactically as it is subject to the zenex, assurity, endurity laser adhesion preparation field safety correction action issued on (b)(6) 2022, which applies to a subset of devices distributed and implanted outside of the united states.During the prophylactic replacement procedure, the set screw of the device could not be loosened.A surgical drill was used to detach the lead from the header of the device.The patient was in stable condition.

Manufacturer Narrative

The reported event was a failure to remove setscrew during the prophylactic explant of a device that was subject to the zenex, assurity, endurity laser adhesion preparation field safety correction action issued on 20 july 2022, which applies to a subset of devices distributed and implanted outside of the united states.The reported event of failure to remove setscrew was confirmed.The device was above elective replacement indicator (eri) and the header was broken into pieces upon receipt.Analysis revealed the right atrial set screw was stripped and contained septum material inside the hex cavity.This material in the hex cavity prevented full insertion of the torque driver and was the cause of the reported event.The damaged set screw was consistent with having occurred during the procedure.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15311757
• MDR Text Key: 298796552
• Report Number: 2017865-2022-21609
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509589
• UDI-Public: 05414734509589
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: PM2272
• Device Catalogue Number: PM2272
• Device Lot Number: P000102751
• 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: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2020
• 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