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

Model Number 401890

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2022

Event Type  malfunction  

Event Description

Non-functioning electrode on jsn catheter.Replaced cable and still did not work.Removed from body and replaced with new catheter.New catheter worked.No harm done to the patient.

• Brand Name: SUPREME
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL CARDIOVASCULAR DIVISION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 15310308
• MDR Text Key: 298779436
• Report Number: 15310308
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 401890
• Device Catalogue Number: 401890
• Device Lot Number: 8350391
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: White