MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. MERLIN PROGRAMMER; PACEMAKER PROGRAMMER

Model Number 3650

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

A burning smell was noted after powering on the programmer.The programmer was replaced to resolve the event and there were no patient consequences.

Manufacturer Narrative

The field complaint of a burning smell and a flickering screen was verified as the event could be reproduced.Troubleshooting revealed the tft backlight inverter anomaly as the root-cause for this issue.No additional findings found not related to the event description.

• Brand Name: MERLIN PROGRAMMER
• Type of Device: PACEMAKER PROGRAMMER
• 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: 7838601
• MDR Text Key: 119273820
• Report Number: 2017865-2018-12922
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 05414734500661
• UDI-Public: 05414734500661
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3650
• Device Catalogue Number: 3650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2009
• 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