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	Communication or Transmission Problem (2896); No Tactile Prompts/Feedback (4024)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an in-clinic follow-up, the programmer's touch screen was responsive but not functioning correctly and the programmer wasn't programming the device as desired.The programmer switched to no pacing mode (odo mode) unprompted.The patient is pacemaker dependent, however no adverse event occurred.A different programmer was used to program back to desired settings.The patient was stable with no consequences.

• 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 MEDICAL; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 25598577
• Report Number: 2017865-2026-12978
• Device Sequence Number: 9972001
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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: 06/08/2026
• Initial Report FDA Received Date: 06/23/2026
• 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