MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. MERLIN@HOME, RF TELEMETRY BASIC; PACEMAKER DATA TRANSMITTER

Model Number EX1150

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The field complaint that the transmitter stopped working and had a bad smell was verified.Visual inspection revealed no anomalies.After opening the ac power adapter burnt components were observed on the main circuit board.A burned mark on the inner casing of the ac power adapter was also noted.Upon opening the transmitter, no damages were observed on the main pcb.The ac power adapter was replaced and the unit powered on successfully.Based on this information, the root cause of the power issue was the damage sustained through a defective ac electrical power outlet.

Event Description

During analysis, burn marks were found on the device.There were no adverse health consequences for the patient.

• Brand Name: MERLIN@HOME, RF TELEMETRY BASIC
• Type of Device: PACEMAKER DATA TRANSMITTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7472843
• MDR Text Key: 106886373
• Report Number: 2017865-2018-05942
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2018

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
• Device Catalogue Number: EX1150
• Other Device ID Number: 05414734504799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 04/30/2018
• 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