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

Model Number 1458Q/75

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

Patient Problems Discomfort (2330); Cardiac Perforation (2513)

Event Date 09/19/2022

Event Type  Injury  

Event Description

It was reported that during an implant procedure that the left ventricular (lv) lead perforated the pericardium.The patient experienced discomfort and the physician elected to complete the procedure without an lv lead.The patient condition was stable.

Manufacturer Narrative

The lead was returned due to cardiac perforation.As received, a complete lead was returned in one piece.Electrical testing was normal.Visual inspection of the lead did not find any anomalies.The s-curve hump height was measured within specification.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15673176
• MDR Text Key: 302413737
• Report Number: 2017865-2022-43118
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503334
• UDI-Public: 05414734503334
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1458Q/75
• Device Catalogue Number: 1458Q-75
• Device Lot Number: A000127131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2022
• 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): Life Threatening
• Patient Age: 84 YR
• Patient Sex: Male