MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) MERLIN@HOME RF VERSION; Pacemaker/icd/crt non-implanted components

Model Number	EX1150W
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event of a no power issue was confirmed by analysis.Final analysis found that upon visual inspection revealed no physical damage to the outer plastic casing of the alternating current (ac) power adapter or to the outer plastic housing of the transmitter.During analysis, a failure event was observed which was unrelated to the reported event.After opening the ac power adapter several burnt components were observed on the main circuit board.Upon opening the transmitter no burnt components were observed.Tested unit with working ac power adapter and unit successfully powered on.Performed the delete data process successfully.High current flow through the ac wall power outlet damaged the ac power adapter causing the no power issue.
Event or Problem Description
This report is to advise of an event observed during analysis.

• Brand Name: MERLIN@HOME RF VERSION
• 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: 23547829
• Report Number: 2017865-2025-1004964
• Device Sequence Number: 18571649
• Product Code: OSR
• UDI-Device Identifier: 05415067034809
• UDI-Public: (01)05415067034809(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): 11/13/2025

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: EX1150W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/13/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown