MAUDE Adverse Event Report: ABBOTT AVEIR¿ PROGRAMMER LINK MODULE; LEADLESS PACEMAKER

Model Number	LSL02
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that loss of capture was observed on the atrial leadless device.A capture threshold test was performed after the output of the device was reprogrammed and capture was observed on the test.However, when comparing the capture threshold test to an external electrocardiogram, there was no capture visible.The patient is dependent on atrial pacing, but did not experience any symptoms or consequences due to the event.The system was reprogrammed to ventricular pacing only to resolve the event, and the patient was in stable condition.

• Brand Name: AVEIR¿ PROGRAMMER LINK MODULE
• Common Device Name: LEADLESS PACEMAKER
• 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: 21599313
• Report Number: 2017865-2025-17419
• Device Sequence Number: 21064169
• Product Code: PNJ
• UDI-Device Identifier: 05415067031914
• UDI-Public: (01)05415067031914(10)WMP129817
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P150035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/30/2025

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: Health Professional
• Device Model Number: LSL02
• Device Lot Number: WMP129817
• Was Device Available for Evaluation?: No
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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