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	Program or Algorithm Execution Failure (4036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an in-clinic follow-up, a noninvasive pacing study (nips) was performed.Burst pacing was initiated using the merlin programmer, however, upon releasing the button on the programmer, the burst pacing did not immediately terminate.The burst pacing continued for about 4 additional seconds before eventually ceasing.The were no adverse consequences due to the prolonged pacing.The patient was in stable condition.
Additional Manufacturer Narrative
¿the reported event of the atrial noninvasive pacing study (nips) continuing for approximately 3-4 seconds after the release of the burst-button was confirmed based on the analysis of the navigation history from the provided session record.The root cause of the incident could not be confirmed without the system logs of the merlin programmer at the time of the event.

• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18084931
• Report Number: 2017865-2023-51813
• Device Sequence Number: 6629634
• Product Code: OSR
• UDI-Device Identifier: 05415067031174
• UDI-Public: 05415067031174
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 02/28/2024

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: 10/23/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown