MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Merlin@home, RF telemetry basic; Pulse Generator, Permanent, Implantable

Model Number	EX1150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The external device was returned.During device analysis charring was observed.
Additional Manufacturer Narrative
The field complaint of the transmitter having a broken usb port was verified.The visual inspection revealed no physical or burn damage to the outer plastic housing of the transmitter.Additionally, the visual inspection revealed that the outer casing of the ac power adapter was melted.The plug adapter (prongs) was removed, and no burn or physical 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.Additionally, the unit exhibited keypad led issues where the only two leds that worked were the 1st and 2nd.All the other icons and leds failed to illuminate, which would have made the delete data process unverifiable.Unable to perform delete data process due to the broken usb port.Upon further inspection, there was no damage to the main printed circuit board (pcb)/inner housing of the transmitter or to the main pcb/inner casing of the ac power adapter.In conclusion, the transmitter did exhibit hardware failure with the keypad where several leds/icons failed to work properly, the melted outer casing did not impede or affect functionality of the unit, and the usb port was broken making the delete data process unable to be performed.

• Brand Name: Merlin@home, RF telemetry basic
• Common Device Name: Pulse Generator, Permanent, Implantable
• Manufacturer (Section D): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 50347321
• Report Number: 2017865-2026-17553
• Device Sequence Number: 17658294
• 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): 08/20/2026

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?: Yes
• Date Returned to Manufacturer: 07/21/2026
• 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: Not provided
• Initial Report FDA Received Date: 08/20/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown