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

Model Number 1458Q/86

Device Problems Break (1069); High impedance (1291); Separation Failure (2547); Capturing Problem (2891)

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

Event Date 02/01/2023

Event Type  Injury  

Event Description

It was reported that the patient presented to the hospital for a follow-up on 1 feb 2023.During examination of lead, it was noted that there was elevated capture threshold and high pacing lead impedance on the left ventricular (lv) lead.After further assessment in clinic, computed tomography (ct) scan showed lv lead was fractured under the clavicle.It was also noted that during implant procedure of lv lead, the stylet could not be removed and was left inside the lv lead the physician explanted and replaced the lv lead on (b)(6) 2023.The patient was in stable condition.

Manufacturer Narrative

The reported events of lead fracture, high pacing threshold, high pacing lead impedance and stylet could not be removed were confirmed while the reported event of clavicle crush was not confirmed.As received, a complete lead was returned in two pieces with the stylet stuck inside both portions of the lead.The style was implanted with the lead.Visual and x-ray examinations of the lead found that all filars of the inner coil and stylet were fractured at the middle region of the lead.The cause of the reported events of high pacing threshold and high pacing lead impedance was isolated to the inner coil fracture.Visual and x-ray examinations also found that the inner coil inside the connector region was bunched up with blood inside the inner coil which is consistent with procedural damage.The cause of the reported event of stylet could not be removed was isolated to the bunching of the inner coil/blood at the connector region.Visual inspection of the lead did not find any signs of clavicle crush damage.

• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16430026
• MDR Text Key: 310089042
• Report Number: 2017865-2023-10631
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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
• Report Date: 04/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: A000122282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2022
• 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 Outcome(s): Required Intervention