MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) MERLIN PROGRAMMER; No Match

Model Number	3650
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event of the leadless pacemaker (lp) continuing in temporary pacing mode after experiencing loss of telemetry during the pacing capture threshold (pct) test was confirmed.Based on review of the information provided, it was determined that the pct test session did not terminate when the programmer issued the command to end communication with the lp because the programmer initiated a new open communication command before the end communication command was received by the lp.Consequently, the lp remained in pct temporary pacing settings.No lp device malfunction was observed.
Event or Problem Description
It was reported that the patient presented in clinic for follow-up.During the ventricular capture testing, it was found that the right ventricular leadless pacemaker lost its conductive telemetry with the programmer and resulted in failure to capture.No intervention was performed.Patient condition was stable.

• 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: 24821453
• Report Number: 2017865-2026-07289
• Device Sequence Number: 6012368
• Product Code: NIK
• UDI-Device Identifier: 05414734500661
• UDI-Public: (01)05414734500661(10)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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?: 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: 03/26/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Female