MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR); PACEMAKER DATA TRANSMITTER

Model Number EX1150

Device Problems Thermal Decomposition of Device (1071); Fire (1245)

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

Event Date 11/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the electrical storm had caused the merlin.Net transmitter power cord to catch on fire.The device was not exchanged.No further information was available.

• Type of Device: PACEMAKER DATA TRANSMITTER
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6233675
• MDR Text Key: 64594626
• Report Number: 2017865-2017-00225
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2017
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2016
• 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