MAUDE Adverse Event Report: IRVINE BIOMEDICAL, INC. (ST JUDE MEDICAL) INQUIRY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	IBI-81105
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Catheter steering system malfunctioning while in the body.No patient harm.

• Brand Name: INQUIRY
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): IRVINE BIOMEDICAL, INC. (ST JUDE MEDICAL); 2375 morse ave; irvine CA 92614
• MDR Report Key: 15657326
• Report Number: 15657326
• Device Sequence Number: 20427337
• Product Code: DRF
• UDI-Device Identifier: 05414734302982
• UDI-Public: (01)05414734302982
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/19/2022
• Report Date (Section F): 10/19/2022

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 Model Number: IBI-81105
• Device Catalogue Number: IBI-81105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Race: White
• Date Report Sent to FDA: 10/19/2022