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

Model Number 1458QL/86

Device Problems Failure to Capture (1081); Failure to Sense (1559); Device Contamination with Body Fluid (2317); Contamination of Device Ingredient or Reagent (2901); Impedance Problem (2950)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

This product is registered as a combination product.

Event Description

It was reported that the patient presented for a new implant.It was noted that the physician placed the left ventricular lead but there was no sensing, impedance or capture.Blood was observed in the wire lumen.The physician suspected a malfunction.The lead was exchanged.The procedure was completed with no other events.The patient was stable.

Manufacturer Narrative

The complete lead was returned for analysis with the reported events of no sensing, no capture, high impedance, and blood in the connector pin at implant.Visual examination verified blood to be found on the inner coil in the connector region since the lead had an open inner lumen.Electrical tests did not find shorts or discontinues on any of the conduction paths.The lead connector passed insertion testing into a test but did not pass insertion testing into the test is-4 connector sleeves.Dimensional analysis of the connector identified an over-sized diameter in a section of the connector boot that may have contributed to the reported field events.

• 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: 11012513
• MDR Text Key: 221559560
• Report Number: 2017865-2020-22910
• 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: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 1458QL/86
• Device Catalogue Number: 1458QL/86
• Device Lot Number: A000102325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR