MAUDE Adverse Event Report: ABBOTT MERLIN PROGRAMMER; Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

Model Number	3650
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the programmer was observed emitting smoke.The programmer was removed from service.There were no adverse health consequences to clinicians or patients.

• Brand Name: MERLIN PROGRAMMER
• Common Device Name: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
• 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: 21910605
• Report Number: 2017865-2025-51234
• Device Sequence Number: 21110642
• Product Code: NIK
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2026

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: 3650
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/17/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 07/25/2025; 09/30/2026
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 07/25/2025; 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2006
• 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
• Patient Sex: Unknown