MAUDE Adverse Event Report: ABBOTT MERLIN PACING SYSTEM ANALYZER; NO MATCH

Model Number	EX3100
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an initial implant procedure, loss of pacing was observed on the pacing system analyzer (psa) due to an interrupted connection.The psa was used throughout the entire procedure.The patient was stable.
Additional Manufacturer Narrative
The field complaint of pacing system analyser (psa) losing connection could not be verified.During analysis, unit was plugged into working 3650 programmer.Psa session was established successfully.Resistive termination tool was connected using patient cables.Impedance levels were in normal range.No error message displayed during analysis.No anomalies found at time of analysis.

• Brand Name: MERLIN PACING SYSTEM ANALYZER
• Common Device Name: NO MATCH
• 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: 23593449
• Report Number: 2017865-2025-1005159
• Device Sequence Number: 21332212
• Product Code: NIK
• UDI-Device Identifier: 05414734503105
• UDI-Public: (01)05414734503105(10)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P030054
• 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): 02/24/2026

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: EX3100
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 02/24/2026
• 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 Sex: Unknown