MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR); NO MATCH

Model Number	3650
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that dependent patient presented in clinic for routine aveir dr check where the patient underwent a ventricular threshold decrement test.It was noted that the leadless pacemaker (lp) appropriately lost capture upon decrementing, however when ending the test, the programmer exhibited a slow response to the command and the computer software took a few seconds to respond and increase threshold.As a result, the patient to became pre-syncopal with symptoms of dizziness due to the lag in pacing support.No intervention was performed as the device function returned to normal after the delay.The patient's condition was stable.

• Common Device Name: NO MATCH
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 22003907
• Report Number: 2017865-2025-53449
• Device Sequence Number: 7136090
• Product Code: NIK
• UDI-Device Identifier: 05414734500661
• UDI-Public: (01)05414734500661(10)
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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: 3650
• 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: 04/21/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 09/23/2025
• 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 Age: 41 YR
• Patient Sex: Male