MAUDE Adverse Event Report: ABBOTT MERLIN¿ 2 PATIENT CARE SYSTEM (PCS) PROGRAMMER; PROGRAMMER, PACEMAKER

Model Number	MER3700
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Following the initial implant procedure when running a manual threshold test, the programmer froze while pacing the left ventricle at 90 bpm.The pacing did not self terminate and the programmer was unresponsive.The programmer was turned off in order to restore normal pacing.After the programmer was restarted, all tests were completed normally.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of the programmer freezing during the manual threshold decrement test was confirmed.Based on the information provided, the active controls were hidden behind a pop-up that could not be exited due to the test commencing, which resulted in the screen being locked during the test.The device was performing as intended.

• Brand Name: MERLIN¿ 2 PATIENT CARE SYSTEM (PCS) PROGRAMMER
• Common Device Name: PROGRAMMER, PACEMAKER
• 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: 16523959
• Report Number: 2017865-2023-13430
• Device Sequence Number: 11361154
• Product Code: OSR
• UDI-Device Identifier: 05415067031174
• UDI-Public: 05415067031174
• 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
• Report Date (Section B): 03/23/2023

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
• Device Catalogue 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: 02/24/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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