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 Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of an event that was observed during analysis.
Additional Manufacturer Narrative
The field complaint of a no power issue was verified.The visual inspection revealed no physical damage to the outer plastic casing of the ac power adapter or to the outer plastic housing of the transmitter.After opening the ac power adapter no burnt components were observed on the main circuit board.The ac power adapter did not have any power due to hardware failure.Upon opening the transmitter, burnt components were observed on the reverse side of the main pcb.Unable to test the unit with a working ac power adapter due to the burn damage that the transmitter main pcb sustained.High current flow through the ac wall power outlet damaged the ac power adapter and burned the transmitter main pcb causing the no power issue.

• 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: 23744021
• Report Number: 2017865-2025-1006785
• Device Sequence Number: 18694345
• Product Code: NVZ
• UDI-Device Identifier: 05414734504799
• UDI-Public: (01)05414734504799(10)
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2025

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: Other
• Device Model Number: EX1150
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/08/2025
• 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 Sex: Unknown