MAUDE Adverse Event Report: ST. JUDE MEDICAL REFLEXION SPIRAL; BI-DIRECTION VARIABLE RADIUS CAT

Model Number	DA02893
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Upon mapping of process of ablation, cs lead 7-8 would not communicate properly as signal designation was blank.Connecting cables were exchanged with same results.Catheter exchanged successfully, case commenced without injury to pt.

• Brand Name: REFLEXION SPIRAL
• Common Device Name: BI-DIRECTION VARIABLE RADIUS CAT
• Manufacturer (Section D): ST. JUDE MEDICAL; minetonka MN 55345
• MDR Report Key: 5973243
• Report Number: MW5064994
• Device Sequence Number: 793589
• Product Code: DRF
• UDI-Device Identifier: 05414734216654
• UDI-Public: (01)05414734216654(17)180930(10)
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/21/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: DA02893
• Device Lot Number: 5246617
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 96