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

Model Number	LSL02
Medical Device Problem Codes	Signal Artifact/Noise (1036); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for a leadless pacemaker implant procedure.During the procedure, it was noted that there was noise on the electrocardiogram (ecg) due to the link module.This led to an inability to verify loss of capture during capture threshold testing.Ultrasound gel was applied and new electrodes were used which help reduce the noise but did not eliminate it.An external defibrillator was used to verify loss of capture.No additional intervention was performed.There were no patient consequences.

• 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: 16687623
• Report Number: 2017865-2023-16405
• Device Sequence Number: 7347222
• Product Code: PNJ
• UDI-Device Identifier: 05415067031914
• UDI-Public: 05415067031914
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2023

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?: 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: 03/15/2023
• Initial Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 3M RED DOT ECG PATCHES; AVEIR LEADLESS PACEMAKER, RIGHT VENTRICLE
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 58 KG