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

Model Number 1458QL/86

Device Problems Break (1069); Loose or Intermittent Connection (1371); Component Missing (2306)

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

Event Date 03/30/2022

Event Type  malfunction  

Event Description

It was reported that a patient's lead had no suture sleeve and had visibly exposed wires extruding from the lead's insulation.This was seen during an initial implant procedure.The faulty lead was not used and replaced.The patient was stable throughout the procedure.

Manufacturer Narrative

Correction: investigation conclusion code (h6) should have reflected unintended user error as the lead experienced procedural damage.

Manufacturer Narrative

Correction: updated medical device component code.

Event Description

New information notes that there was no suture sleeve present before the implant.The physician does not believe it came off before implantation, meaning it was not included.

Manufacturer Narrative

The reported events of insulation damaged and ¿no suture sleeve present¿ were confirmed.As received, a complete lead was returned and no suture sleeve was returned for analysis.Visual analysis noted the outer insulation was cut / damaged in the middle region with one cable protruding out the lead body.Electrical testing did not find any indication of conductor fractures or internal shorts.All damages found are consistent with procedural damage.Dhr was reviewed and traceability of suture sleeve was included and the lead passed all quality control tests prior to its distribution.Therefore, it is possible that the suture sleeve was removed from the lead at the same time the lead body was damaged at attempted implant.

• 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: 14103331
• MDR Text Key: 289193644
• Report Number: 2017865-2022-07749
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510219
• UDI-Public: 05414734510219
• 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,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1458QL/86
• Device Catalogue Number: 1458QL/86
• Device Lot Number: A000120469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2022
• 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
• Treatment: QUADRA ALLURE; TENDRIL RIGHT ATRIAL LEAD; TENDRIL RIGHT VENTRICULAR LEAD
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 129 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White