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

Model Number 1458Q/86

Device Problems Product Quality Problem (1506); Failure to Sense (1559); Fitting Problem (2183); No Pacing (3268)

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

Event Date 12/08/2021

Event Type  malfunction  

Event Description

It was reported that during an implant procedure, a left ventricular lead was unable to sense or pace.This was later attributed to be due to damaged pacing system analyzer (psa) cables.It was also noted that the lead had problems with fitting the connector sleeve on its body.The lead was not used and a different lead was implanted.There were no patient consequences.

Manufacturer Narrative

The reported events of lead would not fit into the is-4 connector sleeve, no pacing and failure to sense were confirmed.As received, a complete lead was returned for evaluation.Electrical tests did not find any shorts or discontinues on any of the conduction paths.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.

• 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: 13056228
• MDR Text Key: 282614909
• Report Number: 2017865-2021-39535
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• 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: A000111741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2021
• 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
• Treatment: DURATACHY RIGHT VENTRICULAR LEAD; PACING SYSTEM ANALYZER; QUADRA ASSURA; TENDRIL RIGHT ATRIAL LEAD
• Patient Age: 72 YR
• Patient Sex: Female