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 Codes	Arrhythmia (1721); Dizziness (2194)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that loss of capture wasn't able to be observed during a capture threshold test.As a result, the patient experienced arrhythmia and dizziness.The capture test was terminated to resolve the event, and the patient was in stable condition.
Additional Manufacturer Narrative
The reported complaint of the no loss of capture being displayed on the programmer via the link module was confirmed.Based on the information provided, it was determined that the loss of capture was not displayed on the programmer due to the impedance mismatch at the skin electrode site.This mismatch results in the display of the signal by the link module being different from that of the external ecg monitor.The source of the mismatch is at the skin electrode interface.Hair, dead skin, skin oil can change the electrode electrical properties of each electrode and cause an impedance mismatch between them.Electrode interface impedance can vary from skin site to skin site due to the presence of hair, dead skin, skin oil, loose electrode, etc.

• 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: 20896339
• Report Number: 2017865-2024-72184
• Device Sequence Number: 12955069
• Product Code: PNJ
• UDI-Device Identifier: 05415067031914
• UDI-Public: (01)05415067031914(10)WMP128317
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 03/18/2025

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: WMP128317
• 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: 11/26/2024
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 03/18/2025
• 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