MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) MERLIN@HOME, RF TELEMETRY BASIC; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	EX1150
Medical Device Problem Codes	Break (1069); Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the power cord of the patient's transmitter was burnt due to a broken plug, and the universal serial bus (usb) port was damaged.The transmitter was replaced, and the patient did not experience any adverse consequences.
Additional Manufacturer Narrative
Correction: section h6 - "thermal decomposition of device" should not have been submitted in adverse event problem in 2017865-2025-1007484.
Event or Problem Description
New information received notes that the patient did not report any allegation regarding the transmitter power cord being burnt.
Additional Manufacturer Narrative
The field complaint of the transmitter having a broken usb port was verified; however, the field complaint of a burnt power cord was not verified.The visual inspection revealed no damage to the outer plastic housing of the transmitter or to the ac power adapter or to the power cord.The visual inspection did confirm the broken usb port.The plug adapter (prongs) was removed, and no damage was noted on the green contact strips.The unit was plugged in to the working ac power outlet and the unit powered on successfully.The unit booted up to sleep mode, which is considered normal behavior for a transmitter.Unable to perform the delete/downgrade process due to the damaged usb port.Upon further inspection, there was no damage to the main pcb of the transmitter or to the main pcb of the ac power adapter.In conclusion, the unit was completely responsive throughout troubleshooting and there was no burn damage noted to any part of the transmitter or ac power adapter.

• Brand Name: MERLIN@HOME, RF TELEMETRY BASIC
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 23835407
• Report Number: 2017865-2025-1007484
• Device Sequence Number: 5032123
• Product Code: NVZ
• UDI-Device Identifier: 05414734504799
• UDI-Public: (01)05414734504799(10)
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2026

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: EX1150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 12/20/2025; 03/09/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 12/31/2025; 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 69 YR
• Patient Sex: Male