MAUDE Adverse Event Report: ABBOTT ASSURITY + DR RF; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	PM2260
Medical Device Problem Code	Unexpected Mode Switch (4076)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a clinic follow-up, the device was observed to be in backup (bvvi) mode due to an unknown cause.The device was explanted and replaced to resolve the event.The patient was stable and will continue to be monitored.
Additional Manufacturer Narrative
The reported event of device in backup mode was confirmed.The device was received in backup mode with normal telemetry communication.Analysis of the device image indicated the cause of backup mode was consistent with an anomalous integrated circuit on the hybrid, which turned the device into reset mode.After the product code was reloaded, the device exhibits normal characteristics.Electrical and mechanical tests performed did not identify any functional issues.Anomalous error and backup condition could not be reproduced.Assessment of total projected longevity was performed and found the battery depletion was normal based on the device usage.

• Brand Name: ASSURITY + DR RF
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 23819378
• Report Number: 2017865-2025-1007434
• Device Sequence Number: 9974451
• Product Code: NVZ
• UDI-Device Identifier: 05414734507097
• UDI-Public: (01)05414734507097(10)4385331(17)150630
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: PM2260
• Device Lot Number: 4385331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown