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	02/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient presented in clinic for the implant procedure.During implant, it was observed the aveir link failed to show loss of capture on the electrocardiogram.The patient was not dependent and did not experience symptoms.The procedure completed without any further issue.The patient was stable.
Additional Manufacturer Narrative
The reported complaint of an anomaly in the links communication was verified.During the analysis the link was connected to a testing programmer via usb and the provided electrocardiogram (ecg) cable was used.The programmer failed to recognize the device due to a defective ecg cable.

• 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: 16414674
• Report Number: 2017865-2023-10552
• Device Sequence Number: 20242044
• Product Code: PNJ
• UDI-Device Identifier: 05415067031914
• UDI-Public: 05415067031914
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/10/2023

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 Catalogue Number: LSL02
• 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: 02/01/2023
• Supplement Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 82 YR
• Patient Sex: Female
• Patient Weight: 84 KG