MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; NO MATCH

Model Number 1458Q/86

Device Problems High impedance (1291); Difficult to Insert (1316); Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented for an implant procedure.During the procedure, it was noted that the left ventricular (lv) lead exhibited high pacing impedance.The lv lead was not used and replaced.The patient was in stable condition.

Manufacturer Narrative

The reported events of high pacing impedance and difficulty to fit the connector sleeve over the lead entirely were confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.The lead connector passed insertion testing into the test icd device but failed to insert into the test is-4 connector sleeve.Dimensional analysis of the connector identified an over-sized diameter in a section of the connector boot.This may have contributed to the reported field events.

Manufacturer Narrative

Correction: h6 medical device problem code updated to difficult to insert, was previously reported as incompatible.

Manufacturer Narrative

A device history record (dhr) review was performed and was found complete.Correction: investigation conclusions code updated to cause traced to manufcaturing.

Manufacturer Narrative

Correction: b5 - corrected b5 to include the fitting issue of the connector sleeve not previously reported.Correction: h6 - corrected h6 to include fitting problem code not previously reported.

Event Description

It was reported that the patient presented for an implant procedure.During the procedure, it was noted that the physician had difficulty fitting the connector sleeve over the left ventricular (lv) and high pacing impedance on the lv lead.The lv lead was not used and replaced.The patient was in stable condition.

• Brand Name: QUARTET
• Type of Device: NO MATCH
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17368512
• MDR Text Key: 319474540
• Report Number: 2017865-2023-36394
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• Reporter Country Code: SN
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: S000086569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2022
• 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