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

Model Number 1458QL/86

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

Patient Problems Perforation (2001); Pleural Effusion (2010)

Event Date 01/04/2020

Event Type  Injury  

Manufacturer Narrative

This product is registered as a combination product.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

Related manufacturer reference number: 2017865-2020-06291, related manufacturer reference number: 2017865-2020-06293, related manufacturer reference number: 2017865-2020-06297.It was reported that the patient was diagnosed with left pleural effusion possibly due to perforation during the implant of the patient's implantable cardioverter defibrillator system.No revision or patient condition was reported.Further information was requested but not received.

Manufacturer Narrative

Additional information: b5.

Event Description

New information received indicated that the pleural effusion sustained by the patient was not related to the implant procedure of the patient's pacemaker system.The physician confirmed the effusion was caused by a transesophageal echocardiogram.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10076043
• MDR Text Key: 191596253
• Report Number: 2017865-2020-06295
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510219
• UDI-Public: 05414734510219
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 1458QL/86
• Device Catalogue Number: 1458QL/86
• Device Lot Number: A000061768
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: QUADRA ALLURE; TENDRIL STS; TENDRIL STS; QUADRA ALLURE; TENDRIL STS; TENDRIL STS
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR