MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 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	04/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient presented in clinic for follow-up with shortness of breath, nausea, and light headedness.Upon interrogation, the link module exhibited artifacts during capture threshold testing.It was determined the leadless pacemaker (lp) exhibited high capture thresholds potentially caused by a microdislodgement found through chest x-rays.Programming changes were implemented.The patient was in stable condition.

• Brand Name: AVEIR¿ PROGRAMMER LINK MODULE
• Common Device Name: LEADLESS PACEMAKER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 19327025
• Report Number: 2017865-2024-41621
• Device Sequence Number: 17894931
• Product Code: PNJ
• UDI-Device Identifier: 05415067031914
• UDI-Public: (01)05415067031914(10)WMP121368
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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: WMP121368
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown