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

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

Patient Problems Arrhythmia (1721); Unspecified Infection (1930); Pneumothorax (2012); Cardiac Perforation (2513); Unspecified Vascular Problem (4441)

Event Type  Injury  

Event Description

The following was published in the egyptian heart journal (2022) titled ¿unguided temporary pacing via jugular/ subclavian vein in an emergency department of a high-volume tertiary care hospital of india: its safety, efcacy, and practicability¿ 74:33 https://doi.Org/10.1186/s43044-022-00271-z, najeeb ullah, md.A total of 1093 patients were enrolled in a study.Temporary pacing is usually performed by cardiologists under fluoroscopic, echocardiographic, or ecg guidance.However, in the developing world, there are inadequate number of cardiologists, and c-arm, catheterization laboratories, or echocardiography are not available at primary or secondary healthcare facilities.In addition, in emergencies option of fluoroscopy and echocardiography is limited.So these patients are transferred to a facility where cardiologists and these facilities are available.Crucial time is lost in transit, which leads to increased mortality.In this study, we aimed to evaluate the safety, efficacy, and practicability of unguided temporary pacemaker insertion.A right ijv perforation occurred due to a temporary pacing lead in a patient who had developed right subclavian and brachiocephalic vein stenosis after permanent pacemaker implantation was done 9 years back (fig.2).In this patient, temporary pacing could not be achieved by jugular or subclavian vein, so a femoral vein approach was required.Subclavian and brachiocephalic vein stenosis has been reported after indwelling devices such as central venous catheters, pacemaker or defibrillator leads, and hemodialysis catheters [6¿8].Venous obstruction has been attributed to thrombus formation or fibrosis caused due to chronic irritation of the endothelium.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the perforation 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: 14876796
• MDR Text Key: 295064008
• Report Number: 2182269-2022-00031
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2023
• 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