MAUDE Adverse Event Report: ABBOTT MERLIN PROGRAMMER; NO MATCH

Model Number	3650
Medical Device Problem Codes	Computer Software Problem (1112); Communication or Transmission Problem (2896); Interrogation Problem (4017)
Health Effect - Clinical Codes	Arrhythmia (1721); Discomfort (2330)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the programmer was unable to program the implanted device to a higher pacing rate.The programmer was turned off and back on, but it took a long time to boot up.As a result, the patient experienced arrhythmia and discomfort.A temporary lead was implanted to pace the patient at an acceptable rate.Additionally, it was noted that the programmer took a long time to interrogate the device in order to reprogram the device.The programmer will be returned and replaced to resolve the event.The patient was in stable condition.
Additional Manufacturer Narrative
The field complaint of bootup anomaly was verified, as the event could be reproduced.The unit was plugged in to an external power source and powered on, however, the system operating system was not found.Troubleshooting revealed hdd (hard drive device) as the root-cause for this issue.

• Brand Name: MERLIN PROGRAMMER
• Common Device Name: NO MATCH
• 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: 21169652
• Report Number: 2017865-2025-10996
• Device Sequence Number: 9412764
• Product Code: NIK
• UDI-Device Identifier: 05414734500661
• UDI-Public: (01)05414734500661(10)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P030054
• 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): 03/03/2025

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: 3650
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 03/03/2025
• 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: Required Intervention; Other
• Patient Sex: Unknown