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

Model Number	MER3700
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a threshold test, the programmer froze and caused a loss of pacing and asystole in a pacemaker dependent patient.The programmer was replaced after the event, but no further intervention has been performed at this time.The patient was stable.
Additional Manufacturer Narrative
The field complaint of a frozen screen was not verified as the event could not be reproduced.No additional findings not related to the event description.The operating system and software was re-installed.All tests were performed per procedure.

• 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: 21868337
• Report Number: 2017865-2025-40561
• Device Sequence Number: 11942432
• Product Code: OSR
• UDI-Device Identifier: 05415067031174
• UDI-Public: (01)05415067031174(10)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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: MER3700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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