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	Discomfort (2330)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a capture threshold test as the capture threshold was decrementing, the patient expressed they were felling strange.Loss of capture occurred; however it was not visible on the electrogram (egm).The capture threshold was recorded so no intervention was performed.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: 21877991
• Report Number: 2017865-2025-50712
• Device Sequence Number: 8768663
• Product Code: PNJ
• UDI-Device Identifier: 05415067031914
• UDI-Public: (01)05415067031914(10)WMP133055
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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: WMP133055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 07/01/2025
• 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