MAUDE Adverse Event Report: ST. JUDE MEDICAL REFLEXION; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number 402804

Device Problem Signal Artifact/Noise (1036)

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

Event Date 10/19/2015

Event Type  malfunction  

Event Description

During the case a spiral catheter was plugged into the device in normal fashion.Signals 7-8 came across and we noticed an artifact came across the monitor, so they unplugged the cable and plugged it back in yet the artifact was still evident.Another catheter was used from the same lot number and worked fine with no issue.

• Brand Name: REFLEXION
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 5207354
• MDR Text Key: 30637643
• Report Number: 5207354
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 402804
• Device Lot Number: 5076879
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2015
• Device Age: 5 MO
• Event Location: Other
• Date Report to Manufacturer: 10/20/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1