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

Model Number 401763

Device Problem Pacing Problem (1439)

Patient Problem Arrhythmia (1721)

Event Date 02/03/2022

Event Type  Injury  

Event Description

Following the placement of the temporary pacemaker, due to poor adherence and the catheter not being able to pace, the patient experienced a drop in heart rate.The ecg showed an escape heart rate, however, the patient's blood pressure and oxygen saturation could not be measured.Cardiopulmonary resuscitation was immediately administered, and intravenous injection of epinephrine was administered, and an adjustment of the electrode position of the temporary pacemaker was conducted.After symptomatic treatment the patient's heart rate recovered to 80 beats per minute.The pacemaker heart rate, blood pressure, and oxygen saturation were then all noted to be normal and there were no adverse consequences to the patient.

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 incident could not be conclusively determined.

• Brand Name: PACEL FLOW DIRECTED 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: 13598982
• MDR Text Key: 286119198
• Report Number: 2182269-2022-00016
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 05414734007856
• UDI-Public: 05414734007856
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K161873
• 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
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 401763
• Device Catalogue Number: 401763
• Device Lot Number: 7767713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2020
• 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