MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; NO MATCH

Model Number 1458Q/86

Device Problems Therapy Delivered to Incorrect Body Area (1508); Failure to Advance (2524); Capturing Problem (2891); Contamination of Device Ingredient or Reagent (2901); Device Dislodged or Dislocated (2923)

Patient Problem Discomfort (2330)

Event Date 11/17/2023

Event Type  Injury  

Event Description

It was reported that the patient presented in clinic due to phrenic nerve stimulation.It was noted that the left ventricular (lv) lead was dislodged, causing the phrenic nerve stimulation as well as high capture thresholds.The dislodgement was discovered via a chest x-ray.While repositioning the lv lead, the physician found it difficult to insert the guidewire due to the presence of blood in lv lead.Ultimately, the physician elected to explant and replace the lv lead.The patient was stable throughout the procedure.

Manufacturer Narrative

The reported events were lead dislodgement, high capture threshold, extra cardiac stimulation, and difficulties inserting the guidewire in the lead due to the presence of blood in the lead.As received, as complete lead was returned in one piece.The reported event of difficulties inserting the guidewire in the lead due to the presence of blood in the lead was confirmed.Visual inspection of the lead found blood inside the lead.X-ray examination found damaged inner coil consistent with procedural damage.Unable to perform guidewire insertion test due to damaged inner coil inside, as received.The cause of the reported event of difficulties inserting the guidewire in the lead due to the presence of blood in the lead was due to the inner coil being damaged and blood inside the lead.The reported event of high capture threshold was not confirmed.Analysis was normal.No anomalies were found.A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• Brand Name: QUARTET
• Type of Device: NO MATCH
• 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: 18256118
• MDR Text Key: 329601554
• Report Number: 2017865-2023-93745
• 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,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1458Q/86
• Device Lot Number: A000136698
• 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: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2023
• 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