MAUDE Adverse Event Report: ABBOTT MERLIN¿ 2 PATIENT CARE SYSTEM (PCS) PROGRAMMER; PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS

Model Number	MER3700
Medical Device Problem Codes	Data Problem (3196); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient experienced a ventricular tachycardia (vt) episode and manual delivery of anti-tachycardia pacing (atp) was attempted using the device.During the manual atp, the programmer froze and the device aborted the manual atp.The device continued with programmed therapy that the physician was able to inhibit using magnet response.The programmer unfroze, and manual atp was again attempted, however, an error message was noted.Additional information was requested.The patient was in stable condition.
Event or Problem Description
Additional information was received indicating the device was reprogrammed.The patient was in stable condition.

• Brand Name: MERLIN¿ 2 PATIENT CARE SYSTEM (PCS) PROGRAMMER
• Common Device Name: PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS
• 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: 23987137
• Report Number: 2017865-2026-00457
• Device Sequence Number: 17317209
• Product Code: OSR
• UDI-Device Identifier: 05415067031174
• UDI-Public: (01)05415067031174(10)
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2026

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: MER3700
• 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: 12/20/2025
• Supplement Date Received by Manufacturer: 01/09/2026; 03/20/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/30/2026; 03/20/2026
• 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
• Patient Sex: Unknown