MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD

Model Number 7122Q/58

Device Problems Difficult to Fold, Unfold or Collapse (1254); Retraction Problem (1536); Failure to Advance (2524); Device Sensing Problem (2917)

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

Event Date 02/10/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented during implant procedure.During procedure, it was noted that the right ventricular lead exhibited varying r wave sensing variation.During reposition, it was noted that the stylet was stuck in the right ventricular lead and the lead's helix could not be extended and retracted.The reported lead was not installed and the procedure was completed with an alternative lead on 10 feb 2023.The patient was in stable condition.

Manufacturer Narrative

The reported events of varying r wave sensing amplitude and stylet insertion difficulty were not confirmed, while the reported event of helix failure to extend and retract was confirmed.As received, a complete lead was returned in one-piece with the helix retracted and clogged with blood and tissue.Final analysis found the cause of the reported event of helix failure to retract and extend to the blood and tissue in the helix region.No other anomalies were identified.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: DEFIBRILLATION LEAD
• 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: 16464898
• MDR Text Key: 310493155
• Report Number: 2017865-2023-11525
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503174
• UDI-Public: 05414734503174
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: P950022
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7122Q/58
• Device Catalogue Number: 7122Q-58
• Device Lot Number: A000133561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 03/30/2023
• Supplement Dates FDA Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2022
• 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: STYLET