MAUDE Adverse Event Report: ABBOTT 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)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
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 several burnt components were observed on the main circuit board, as well as to the inner casing of the ac power adapter.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
The external device was returned.During device analysis burnt components were observed.

• Brand Name: MERLIN@HOME, RF TELEMETRY BASIC
• Common Device Name: Pulse generator, permanent, implantable
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 23650855
• Report Number: 2017865-2025-1005548
• Device Sequence Number: 11954490
• Product Code: NVZ
• UDI-Device Identifier: 05414734504799
• UDI-Public: (01)05414734504799(10)
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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: EX1150
• 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: 11/14/2025
• Initial Report FDA Received Date: 11/25/2025
• 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