MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 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 Codes	Arrhythmia (1721); Dizziness (2194)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 2017865-2025-17541.It was reported that during an in-clinic follow-up, while performing regular threshold testing, the programmer exhibited a threshold testing decrement issue and the implantable cardioverter defibrillator (icd) exhibited loss of capture, which resulted in patient experiencing an arrhythmia.It was noted that after the testing was completed and the icd was returned to programmed settings, the patient experienced dizziness.No intervention was performed.Patient condition was unknown.
Additional Manufacturer Narrative
It was reported that the threshold test continued to decrement when the button on the merlin programmer was released.The provided information was reviewed by abbott engineering and it was determined that the threshold decrement test was performing per design.Due to the patient requiring a higher pacing amplitude, the current settings were not sufficient to allow for capture.Based on analysis, it took 3 cycles to revert to the programmed amplitude.The last 2 cycles, before capture was restored, was being paced at 3.5 v as expected, but it did not result in capture in the lv chamber due to wedensky effect.

• Brand Name: MERLIN¿ 2 PATIENT CARE SYSTEM (PCS) PROGRAMMER
• Common Device Name: PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS
• 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: 21612847
• Report Number: 2017865-2025-17540
• Device Sequence Number: 18066093
• Product Code: OSR
• UDI-Device Identifier: 05415067031174
• UDI-Public: (01)05415067031174(10)
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

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: 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: 02/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 05/06/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DURATA; QUARTET; TENDRIL
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male