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 Failure to Capture (1081); Difficult to Fold, Unfold or Collapse (1254); Over-Sensing (1438); Retraction Problem (1536); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Discomfort (2330)

Event Type  Injury  

Event Description

It was reported the patient presented with a right ventricular lead that was oversensing r-waves.The oversensing triggered inappropriate shock, which caused the patient pain.The lead exhibited a failure to capture.An x-ray was performed and revealed the lead had dislodged.The physician attempted to revise the lead; however, the helix could not be extended or retracted.The lead was explanted and replaced.The patient was in stable condition.

Event Description

Related manufacturer reference number: 2017865-2024-02037.New information received indicated the patient reported to the emergency room where the reported events were discovered.

Manufacturer Narrative

The awareness date should be (b)(6) 2024 for the initial report, not (b)(6) 2024.

Manufacturer Narrative

The reported events were noise, lead dislodgement, failure to capture, inappropriate shock, and helix mechanism issue.A complete lead was returned in one piece with the helix found retracted and clogged with blood/ tissue.The reported event of helix mechanism issue was confirmed.Visual and x-ray examinations found the inner coil was overtorqued inside the connector region consistent with procedural damage.After cleaning the helix and cutting the lead, the helix was able to extend and retract by applying torque directly to the inner coil.The full helix extension length was measured within specification.The cause of helix mechanism issue was due to the helix being clogged with blood/ tissue and overtorque of the inner coil.The reported events of noise and failure to capture were not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.

• 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: 18584874
• MDR Text Key: 333772579
• Report Number: 2017865-2024-01617
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503174
• UDI-Public: 05414734503174
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P950022
• 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
• Report Date: 02/13/2024

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: A000148451
• 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: 01/08/2024
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2023
• 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
• Treatment: GALLANT
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 91 KG