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

Model Number 401771

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Type  Injury  

Event Description

The patient was hospitalized for chest pain, dizziness and bradycardia and a transthoracic echo revealed a pericardial effusion in the right ventricle.The patient was discharged.No additional information is available.

Event Description

The patient was hospitalized for chest pain, dizziness and bradycardia and a transthoracic echo revealed a pericardial effusion in the right ventricle.The patient was discharged.No additional information is available.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history records for each possible batch number (8670542 or 8462657) were reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported effusion remains unknown.

• Brand Name: PACEL BIPOLAR PACING CATHETER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17360711
• MDR Text Key: 319388596
• Report Number: 2182269-2023-00035
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K152784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 401771
• Device Catalogue Number: 401771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 08/01/2023
• Supplement Dates FDA Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other