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

Model Number 1458Q/75

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2020

Event Type  malfunction  

Manufacturer Narrative

This product is registered as a combination product.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that during initial implant, the guide-wire was unable to be inserted into the lumen of the left ventricular lead.The lead was explanted and a new lead was implanted successfully on (b)(6) 2020.There were no patient consequences throughout.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• 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: 10084098
• MDR Text Key: 191870717
• Report Number: 2017865-2020-06543
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503334
• UDI-Public: 05414734503334
• 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: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 1458Q/75
• Device Catalogue Number: 1458Q-75
• Device Lot Number: A000085265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 05/22/2020
• Supplement Dates Manufacturer Received: 05/28/2020
• Supplement Dates FDA Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1