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

Model Number EX1150

Device Problems Break (1069); Thermal Decomposition of Device (1071)

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

Event Date 03/28/2024

Event Type  malfunction  

Event Description

It was reported that the patient's transmitter caught on fire.The transmitter was broken and suffered thermal damage.A replacement product was sent.There were no patient consequences.

Manufacturer Narrative

The transmitter was received due to burnt plug and physical damage.The complaint of damaged and burnt unit was verified.Visual inspection revealed burn damage to the power adapter plug.Due to damage, the unit could not be plugged in for power verification.No other anomalies were identified.

• 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: 19135150
• MDR Text Key: 340509209
• Report Number: 2017865-2024-39035
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734504799
• UDI-Public: (01)05414734504799(10)
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2024

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?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 05/09/2024
• Supplement Dates FDA Received: 05/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male