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

Model Number	3650
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a programmer became frozen during the sense test for a right atrial (ra) leadless pacemaker (lp).The lp had been programmed to a lower pacing rate for the test and there was no way to end it or reprogram.The test was also unsuccessful as the lp failed to sense, which was the same result from implant.The programmer power supply was accidentally unplugged, but the ra lp was still set to the lower pacing rate and unable to sense.The programmer test was then successfully ended on its own.Patient was stable with no other symptoms.
Additional Manufacturer Narrative
Further information was requested but not received.

• Brand Name: MERLIN PROGRAMMER
• Common Device Name: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
• 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: 50107404
• Report Number: 2017865-2026-16122
• Device Sequence Number: 10032550
• Product Code: NIK
• UDI-Device Identifier: 05414734500661
• UDI-Public: 05414734500661
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/31/2026

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: 07/15/2026
• Initial Report FDA Received Date: 07/31/2026
• 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 Sex: Unknown