MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD DOUBLE BEND, 86 CM; PERMANENT PACEMAKER ELECTRODE

Model Number 1457Q/86

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

Patient Problems Chest Pain (1776); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Pleural Effusion (2010); Sepsis (2067); Discomfort (2330)

Event Date 02/04/2018

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the patient presented to the emergency room on (b)(6) 2018 with chest pains, discomfort and dyspnea due to pleural effusion.A chest tube was inserted.On (b)(6) 2018 the patient was admitted to the intensive care unit with hypotension and sepsis.The patient was started on intravenous antibiotics.The chest tube was noted to be draining fluid and imaging confirmed the bilateral pleural effusion with suspicion of empyema.The patient's left arm was swollen.On (b)(6) 2018 a left arm ultrasound confirmed the presence of focal thrombosis on the left internal jugular vein.On (b)(6) 2018 the patient underwent a surgical procedure to remove the chest tube and a pleuroscopy was performed in which fluid was drained.A second chest tube was inserted and the patient was then transferred back to critical care unit in stable condition.The patient tolerated the procedure well.

• Brand Name: QUARTET LEAD DOUBLE BEND, 86 CM
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7373387
• MDR Text Key: 103554333
• Report Number: 2017865-2018-04242
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030054/S314
• 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: 03/27/2018

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: 10/31/2020
• Device Model Number: 1457Q/86
• Device Lot Number: A000047281
• Other Device ID Number: 05414734510189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2017
• 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
• Treatment: (B)(4); (B)(4); (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention