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

Model Number 7122Q/58

Device Problems Difficult to Fold, Unfold or Collapse (1254); Retraction Problem (1536); Device Dislodged or Dislocated (2923)

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

Event Date 01/18/2024

Event Type  Injury  

Event Description

It was reported the patient presented with a right ventricular lead which became dislodged.The physician attempted to reposition the lead; however, the helix could not be moved.The lead was explanted and replaced.The patient was in stable condition.

Manufacturer Narrative

Further information was requested but not received.

Manufacturer Narrative

The reported events were lead dislodgement and helix mechanism issue.A complete lead was returned in one piece for analysis.The reported event of helix mechanism issue was confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual inspection found the helix fully extended and clogged with blood.X-ray examination found over-torqued of the inner coil at the connector region and stretched helix at the helix region consistent with procedural damage.The helix mechanism/extension length test could not be performed due to the helix being damaged and clogged with blood.The cause of helix mechanism issue was isolated to helix being damaged, helix clogged with blood, and over-torque of the inner coil.

Event Description

Additional information received indicates the lead dislodgement was identified through diagnostic imaging.The helix could not be retracted or extended.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 18659686
• MDR Text Key: 334766510
• Report Number: 2017865-2024-03977
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): Y
• Reporter Country Code: IN
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7122Q/58
• Device Lot Number: A000146565
• 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: 01/20/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 02/14/2024; 03/25/2024
• Supplement Dates FDA Received: 02/16/2024; 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2023
• 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