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

Model Number 401763

Device Problem Break (1069)

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

Event Date 08/22/2018

Event Type  malfunction  

Event 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
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7845449
• MDR Text Key: 119235235
• Report Number: 7845449
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 05414734007856
• UDI-Public: (01)05414734007856
• 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: 08/23/2018

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
• Device Operator: Health Professional
• Device Model Number: 401763
• Device Catalogue Number: 401763
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Weight: 81