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

Model Number EX1150

Device Problems Thermal Decomposition of Device (1071); Failure to Power Up (1476)

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

Event Date 02/02/2024

Event Type  malfunction  

Event Description

It was reported that the patient's merlin@home transmitter failed to power up.The patient stated that one of the transmitter power adaptor prongs stayed in the power outlet.The prong was burnt and broke off the power adapter.The patient was advised to discontinue use of the transmitter.There were no adverse patient consequences.

Manufacturer Narrative

The reported event of failure to power was confirmed.As received, the transmitter had damaged power adapter plug.Visual inspection did not find damage on the housing was observed.Upon opening the transmitter and power adapter, no damage was found.After replacing the power adapter, the transmitter successfully powered on.The caused of the reported event was isolated to the damaged power adapter.

• Brand Name: MERLIN@HOME, RF TELEMETRY BASIC
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18751529
• MDR Text Key: 335901289
• Report Number: 2017865-2024-33192
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734504799
• UDI-Public: 05414734504799
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2024

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: Lay User/Patient
• Device Model Number: EX1150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Sex: Female