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

Model Number	EX1150
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the transmitter would not power on due to a burnt power adapter.The transmitter was not used and replaced.No patient consequences were reported.
Additional Manufacturer Narrative
Further information was requested but not received.
Additional Manufacturer Narrative
The field complaint of a no power issue caused by a burnt power adapter was verified.The visual inspection revealed burn damage to the plug adapter of the ac power adapter and one of the prongs was gone.There was no visible burn or physical damage to the outer plastic housing of the transmitter.After opening the ac power adapter several no burnt components were observed on the main circuit board, or 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 melted the plug adapter causing the no power issue.
Additional Manufacturer Narrative
Correction: g2 - report source was updated to reflect that the company representative box was checked.

• 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: 25024952
• Report Number: 2017865-2026-08747
• Device Sequence Number: 8964092
• Product Code: NVZ
• UDI-Device Identifier: 05414734504799
• UDI-Public: (01)05414734504799(10)
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2026

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: 04/09/2026
• Supplement Date Received by Manufacturer: 06/23/2026; 07/06/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 06/29/2026; 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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