MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) MERLIN PROGRAMMER; NO MATCH

Model Number	3650
Medical Device Problem Codes	Interrogation Problem (4017); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	04/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented post implant procedure for follow-up.Upon device interrogation, there was i2p interruption while performing an atrial sense test.The programmer then froze and had to be restarted as a result.During this time the patient experienced bradycardia for longer than expected.After turning the programmer off and then back on the pacing base rates were successfully re-established.The patient was in stable condition.

• Brand Name: MERLIN PROGRAMMER
• Common Device Name: NO MATCH
• Manufacturer (Section D): ABBOTT MEDICAL (CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT MEDICAL (CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 24927920
• Report Number: 2017865-2026-08119
• Device Sequence Number: 14797727
• Product Code: NIK
• UDI-Device Identifier: 05414734500661
• UDI-Public: (01)05414734500661(10)
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3650
• 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: 04/02/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 18 YR
• Patient Sex: Male
• Patient Weight: 68 KG