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 Information (3190)

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

Failure event observed during analysis.Final analysis found that upon opening the ac power adapter, inspection revealed that there were burnt components on both sides of the main pcb.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.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.

Event Description

This report is to advise of an event observed during analysis.

• 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8189468
• MDR Text Key: 131156791
• Report Number: 2017865-2018-18755
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 05414734504799
• UDI-Public: 05414734504799
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: EX1150
• Device Catalogue Number: EX1150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2018
• 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