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

Model Number 1456Q/86

Device Problem Use of Device Problem (1670)

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

Event Date 11/16/2022

Event Type  malfunction  

Event Description

Related manufacture reference number: 2017865-2022-47615.It was reported that the patient presented prior to generator exchange procedure.Upon interrogation, it was noted that the right ventricular lead exhibited high pacing impedance and high capture threshold.During procedure, it was noted lead was not secured in the header.The reported lead was capped and replaced on 16 nov 2022.During replacement, it was noted that the newly implanted left ventricular could not be implanted as the shape of the lead prevented the lead from advancing.The left ventricular lead was not installed and the procedure was completed with an alternative lead.The patient was in stable condition.

Event Description

Related manufacture reference number: 2017865-2022-48393.Related manufacture reference number: 2017865-2022-47615.It was reported that the patient presented prior to generator exchange procedure.Upon interrogation, it was noted that the right ventricular lead exhibited high pacing impedance and high capture threshold.During procedure, it was noted lead was not secured in the header.The reported lead was explanted and replaced on 16 nov 2022.During replacement, it was noted that the newly implanted left ventricular could not be implanted as the shape of the lead prevented the lead from advancing.The left ventricular lead was not installed and the procedure was completed with an alternative lead.The patient was in stable condition.

Manufacturer Narrative

The reported event was unable to implant was not confirmed.As received, a complete lead was returned for analysis.Electrical testing, visual inspection, and x-ray did not find any anomalies.

• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15912652
• MDR Text Key: 306783006
• Report Number: 2017865-2022-47617
• 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,Followup
• Report Date: 12/19/2022

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: A000128928
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/04/2022
• Supplement Dates Manufacturer Received: 11/21/2022; 12/08/2022
• Supplement Dates FDA Received: 12/13/2022; 12/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2022
• 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: 67 YR
• Patient Sex: Male