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 Date 10/10/2018

Event Type  malfunction  

Event Description

After plugging the transmitter into power, the power supply was observed to emit smoke and sparks.The issue was resolved by removing and replacing the transmitter.The patient was in stable condition and experienced no adverse health consequences.

Manufacturer Narrative

The field complaint of the transmitter's power supply emitting smoke and sparks was not verified as the event could not be reproduced; however, there was burn damage revealed that could have been the initial cause of the smoke.The visual inspection revealed no physical damage to the outer housing of the merlin@home transmitter and no physical damage to the outer casing of the ac power adapter.The prongs were removed from the ac power adapter to inspect for damage, and a strong burnt odor was found emitting from the ac power adapter.Thus the unit was not plugged into a working ac electrical outlet.Upon opening the ac power adapter, inspection revealed that there were burnt components on both sides of the main pcb and on its¿ inner casing.Inspection of the opened transmitter revealed that there was no damage to the main pcb or to its inner housing.The original ac power adapter was replaced to test the transmitter with the ac power adapter tl# (b)(4).The unit was then plugged into a working ac electrical wall outlet and the power on function was performed successfully.The test revealed that the burnt damage to the original ac power adapter was the cause of the no power issue.As a result, we can conclude that the transmitter was hit by a high current flow through the ac wall power outlet into the ac power adapter, thus damaging its main pcb.

• 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: 7978047
• MDR Text Key: 124134261
• Report Number: 2017865-2018-15497
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 05414734504799
• UDI-Public: 05414734504799
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/10/2018
• Initial Date FDA Received: 10/18/2018
• Supplement Dates Manufacturer Received: 10/25/2018; 12/12/2018
• Supplement Dates FDA Received: 10/26/2018; 12/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2018
• 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