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

Model Number 1458Q/86

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Difficult to Insert (1316); Failure to Sense (1559)

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

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

This product is registered as a combination product.

Event Description

It was reported that during an implant, no sensing, high, out of range impedance, and noise were observed.All connections checked.It was noted that the is4 adaptor was not fitting lead well, and a new one was provided.However, unable to test the lead.The left ventricular lead was replaced with no issues.There were no adverse health consequences to the patient.

Manufacturer Narrative

The complete lead was returned with the associated is-4 psa connector sleeve for analysis with the reported events of no sensing and high lead impedance due to the is-4 adapter not fitting the lead well.Electrical tests did not find shorts or discontinues on any of the conduction paths.The lead connector passed insertion testing into a test device but did not pass insertion testing into the returned is-4 connector sleeve.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-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10823079
• MDR Text Key: 215946989
• Report Number: 2938836-2020-09214
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• 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: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: A000099625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 110