MAUDE Adverse Event Report: ST JUDE MEDICAL, INC. REFLEXION SPIRAL VARIABLE RADIUS MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number D402804

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Once the catheter was inserted, a bad signal was noted on the esi system.Changed out a cable and it did not resolve the problem; a new catheter was replaced and still the signals came across as bad.Rechecked all connections, replaced the catheter a second time, rechecked and signals were good after second catheter from same lot# replaced the first one.The rep was in the room so devices were given to the rep so they could be replaced.

• Brand Name: REFLEXION SPIRAL VARIABLE RADIUS MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST JUDE MEDICAL, INC.; one st. jude medical drive; saint paul MN 55117
• MDR Report Key: 4320803
• MDR Text Key: 5129691
• Report Number: 4320803
• Device Sequence Number: 1
• Product Code: DRF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 11/20/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: D402804
• Device Lot Number: 4707836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/20/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NOT AWARE
• Patient Age: 67 YR