MAUDE Adverse Event Report: ABBOTT VERITY ADX XL VDR; implantable pacemaker Pulse-generator

Model Number	5456
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No complaint was received with the return of the device.Failure event observed during analysis.Final analysis found that the device had no output and no telemetry, unable to be interrogated upon receipt.Device x-ray showed no anomaly, it was cut-open and battery voltage measurement indicates the device was at beginning of life (bol) level.The device reverted to backup mode, and the code was reloaded and interrogated under nominal conditions normally.The cause of the pacing and telemetry issue is consistent with an integrated circuit anomaly.Longevity assessment was performed, and the device was in the normal range of operation with appropriate remaining longevity.
Event or Problem Description
This report is to advise of an event observed during analysis.

• Brand Name: VERITY ADX XL VDR
• Common Device Name: 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: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 24590436
• Report Number: 2017865-2026-04809
• Device Sequence Number: 9440541
• Product Code: DXY
• UDI-Device Identifier: 05414734006910
• UDI-Public: (01)05414734006910(10)P000200664(17)251130
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2026

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
• Operator of Device: Other
• Device Expiration Date: 11/30/2025
• Device Model Number: 5456
• Device Lot Number: P000200664
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2024
• 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
• Patient Sex: Unknown