MAUDE Adverse Event Report: ABBOTT MERLIN@HOME, RF TELEMETRY BASIC; Pulse generator, permanent, implantable

Model Number EX1150

Device Problems Thermal Decomposition of Device (1071); Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2023

Event Type  malfunction  

Event Description

It was reported, the rf transmitter exploded on the table in the patient's home.The patient was not harmed and no fire was reported, only smoke from the transmitter.

Manufacturer Narrative

The field complaint of the unit smoking was verified.The visual inspection revealed no damage to the outer plastic housing of the transmitter as well as the ac power adapter.The unit was plugged in to the working ac power outlet and the unit powered on successfully.Delete data process was performed successfully.Upon opening the ac power adapter, no burn damage was found on the main pcb.After opening the transmitter, smoke damage was revealed on the inside of the transmitter housing.Burn damage was found on the main pcb of the transmitter.High current flow through the ac wall power outlet may have been the cause for the damage and smoking of the transmitter main pcb.

• Brand Name: MERLIN@HOME, RF TELEMETRY BASIC
• Type of Device: 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 19072372
• MDR Text Key: 339730585
• Report Number: 2017865-2024-38032
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734504799
• UDI-Public: (01)05414734504799(10)
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2024

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
• Device Operator: Health Professional
• Device Model Number: EX1150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1