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

Model Number JSN

Device Problem Communication or Transmission Problem (2896)

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

Event Date 07/26/2016

Event Type  malfunction  

Event Description

A catheter was inserted in to patient; we were unable to obtain a signal.We tried switching pins and cable before changing out to another catheter.The catheter was new and after switching our cables and still getting poor signals, the catheter was switched out to a new one.No harm was done to the patient.

• Brand Name: SUPREME
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 6379986
• MDR Text Key: 69123480
• Report Number: 6379986
• 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: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: JSN
• Device Catalogue Number: 401443
• Device Lot Number: 5458160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 83 YR