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

Model Number	3650
Medical Device Problem Code	Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that the pacing capture threshold (pct) test failed to terminate after loss of telemetry was confirmed.Based on the information reviewed, it was determined that the command to close the telemetry channel and to terminate the pct test was not triggered by the merlin pcs programmer following the loss of telemetry.It was confirmed that in the following session, after the field reduced the rhythm and power of stimulation of the catheter, good telemetry communication resumed, and implant was finalized.
Event or Problem Description
It was reported that the patient presented to the hospital for a leadless pacemaker (lp) implant procedure.While conducting a pacing capture threshold (pct) test, telemetry was lost between the lp and programmer.The capture test could not be terminated, and the programmer was turned off.Afterwards, it was difficult to re-establish telemetry and the implant could not be finalized.It was suspected that the loss of telemetry was due to noise interference from a pacing catheter which was required to stimulate the patient who was pacemaker dependent.The physician then reduced the rhythm and power from the pacing catheter, and they were able to re-establish telemetry and finalize the implant for the lp.There was no adverse consequence to the patient and the patient remained 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: 24821195
• Report Number: 2017865-2026-07287
• Device Sequence Number: 14955447
• Product Code: NIK
• UDI-Device Identifier: 05414734500661
• UDI-Public: (01)05414734500661(10)
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: 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 Sex: Unknown