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

Model Number	EX1150
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the merlin transmitter displayed a read error.Upon visual inspection, the silver strips within the power plug appeared burned.As a result, the transmitter was not used and was replaced.No patient consequences were reported.
Additional Manufacturer Narrative
The reported complaint of wireless communication problem was verified; however, the allegation of thermal decomposition of the device could not be confirmed.Visual inspection identified no damage to the transmitter outer housing or ac power adapter.Examination of the plug adapter after removal revealed no burn marks or physical damage to the metal contact pins.Functional evaluation demonstrated that the unit powered on to the read icon with all leds blinking.During troubleshooting, the start button was found to be stuck, causing the transmitter to reset upon connection to power, consistent with the reported complaint.The delete data process could not be completed due to a hardware failure.Further inspection revealed no damage to the transmitter main pcb, inner housing, ac power adapter main pcb, or inner casing.Analysis determined that the transmitter exhibited a hardware failure involving the keypad, with the start button and several leds/icons failing to operate properly.

• 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: 25157458
• Report Number: 2017865-2026-09974
• Device Sequence Number: 9581967
• Product Code: NVZ
• UDI-Device Identifier: 05414734504799
• UDI-Public: (01)05414734504799(10)
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2026

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: 04/23/2026
• Supplement Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 07/21/2026
• 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 Age: 63 YR
• Patient Sex: Unknown