MAUDE Adverse Event Report: ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC. PACEL¿; ELECTRODE, PACEMAKER, TEMPORARY

Model Number	401763
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient had a temporary pacemaker wires taped to leg and allegedly broke while getting up.It appears to have come apart at the middle of the catheter not at an end or hub.

• Brand Name: PACEL¿
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 21525365
• Report Number: 21525365
• Device Sequence Number: 20946198
• Product Code: LDF
• UDI-Device Identifier: 05414734007856
• UDI-Public: (01)05414734007856(17)260430(10)10521773
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 02/17/2025
• Report Date (Section F): 02/17/2025

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 Model Number: 401763
• Device Catalogue Number: 401763
• Device Lot Number: 10521773
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2025
• 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 Age: 79 YR
• Patient Sex: Male
• Date Report Sent to FDA: 02/17/2025