MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) AVEIR¿ PROGRAMMER LINK MODULE

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	11/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the asymptomatic patient presented in clinic for a follow up.During capture threshold testing, it was observed the aveir programmer link module electrocardiography morphology display did not change when loss of capture was reached.The capture threshold test was terminated.No intervention was required.The patient was stable.
Additional Manufacturer Narrative
The reported event of failure to show loss of capture was not confirmed.During analysis, the link was plugged into a testing programmer no power up issues were found.The link module was tested and successfully able to pick up the aveir device signals.No interrogation anomalies found at the time of analysis.

• Brand Name: AVEIR¿ PROGRAMMER LINK MODULE
• Common Device Name: PROGRAMMER LINK
• 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: 15838870
• Report Number: 2017865-2022-46079
• Device Sequence Number: 12257870
• Product Code: PNJ
• UDI-Device Identifier: 05415067031914
• UDI-Public: 05415067031914
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2023

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: WMP119113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/07/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AVEIR LEADLESS PACEMAKER
• Patient Age: 75 YR
• Patient Sex: Female