MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD SMALL-S, 86 CM; PERMANENT PACEMAKER ELECTRODE

Model Number 1456Q/86

Device Problems Break (1069); Separation Failure (2547); Device Dislodged or Dislocated (2923)

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

Event Date 09/07/2022

Event Type  malfunction  

Event Description

It was reported a patient presented for an implant procedure on (b)(6) 2022.During procedure, the left ventricular lead presented with dislodgement and the stylet became stuck and damaged the lead.The lead was replaced within the same operation.Post-procedure the patient was stable.

Manufacturer Narrative

The reported events were lead dislodgement, insulation damage and stuck stylet.As received a lead was returned in one piece with stylet stuck inside the lead.S-curve height of the lead was measured within specification.The reported events of insulation damage and stuck stylet were confirmed.Visual inspection of the lead found the insulation was damaged at adjacent to the connector boot region.The ptfe coating of the stylet was found stripped and bunched up with the inner coil distal to connector pin.The connector pin and crimp sleeve were found pulled out of the connector assembly and the inner coil was stretched consistent with excessive forces during procedure.The cause of the reported events of insulation damage and ¿stuck stylet¿ was isolated to the bunching of stripped stylet ptfe coating and inner coil at the connector region and excessive forces resulted in the connector pin and crimp sleeve to be pulled out of the connector assembly.

• Brand Name: QUARTET LEAD SMALL-S, 86 CM
• 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: 15439881
• MDR Text Key: 305878798
• Report Number: 2017865-2022-38381
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510158
• UDI-Public: 05414734510158
• 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
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1456Q/86
• Device Catalogue Number: 1456Q/86
• Device Lot Number: A000121672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 09/16/2022
• Supplement Dates Manufacturer Received: 10/07/2022
• Supplement Dates FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2022
• 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
• Patient Age: 72 YR
• Patient Sex: Female