MAUDE Adverse Event Report: ST. JUDE MEDICAL PACEL; ELECTRODE, PACEMAKER, TEMPORARY

Model Number	401763
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Initial temporary pacing wire was opened; prior to insertion balloon was tested; balloon was found to be faulty; product was removed from table; second temporary pacer opened and balloon tested.Second item then inserted.Procedure continued uneventful.

• Brand Name: PACEL
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7845449
• Report Number: 7845449
• Device Sequence Number: 1565332
• Product Code: LDF
• UDI-Device Identifier: 05414734007856
• UDI-Public: (01)05414734007856
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/23/2018
• Report Date (Section F): 08/23/2018

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: 401763
• Device Catalogue Number: 401763
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 81
• Date Report Sent to FDA: 08/23/2018