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

Model Number 401771

Device Problem Loss of Threshold (1633)

Patient Problem Cardiac Arrest (1762)

Event Date 09/12/2021

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported pacing issue could not be conclusively determined.

Event Description

On (b)(6) 2021, the patient was admitted to the emergency department due to battery depletion of the original pacemaker and temporary pacing using a temporary pacemaker was considered.During the implantation of the temporary pacemaker, the appropriate pacing position in the right ventricle could not be found and the pacing threshold was significantly increased.The issue was not resolved after searching for the appropriate potential multiple times.Following the temporary pacing implantation, the patient was noted to be poorly driven by pacing and was returned to the catheterization laboratory to adjust the electrode position, during which cardiac arrest occurred at one time and was treated by utilizing cardiopulmonary resuscitation.On september 12, the patient underwent an emergency permanent pacing implantation again due to increased threshold because the temporary pacemaker could not be driven.The permanent pacing electrode had a good threshold and a good position.The patient was noted to be in a stable condition.

• 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: 12715002
• MDR Text Key: 280115531
• Report Number: 2182269-2021-00079
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 05414734001137
• UDI-Public: 05414734001137
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K152784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2021

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 Expiration Date: 02/28/2023
• Device Model Number: 401771
• Device Catalogue Number: 401771
• Device Lot Number: 7445561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2020
• 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): Required Intervention