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

Model Number PM2272

Device Problems Pacemaker Found in Back-Up Mode (1440); Inappropriate or Unexpected Reset (2959)

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

Event Date 01/01/2024

Event Type  malfunction  

Event Description

It was reported that the device was in backup mode and could not be interrogated.Device explant was anticipated to resolve the event.The patient was stable and there were no adverse consequences.

Manufacturer Narrative

The reported event of device in backup mode was confirmed.The backup mode condition was observed in the field but could not be reproduced in the lab due to lack of telemetry communication and no output.The device was cut open to enable further testing and the battery was found at elective replacement levels.Extra power consumption was observed during analysis and isolated to the defective integrated circuit (ic), which drained the battery prematurely and resulting in the reported event.

Event Description

It was reported that the device was in backup mode and could not be interrogated.The device was explanted and replaced to resolve the event.The patient was stable and there were no adverse consequences.

• 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: 18479803
• MDR Text Key: 332491214
• Report Number: 2017865-2024-00805
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509589
• UDI-Public: 05414734509589
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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 Lot Number: P000102376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 01/12/2024; 03/20/2024
• Supplement Dates FDA Received: 01/31/2024; 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2020
• 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