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

Model Number 7120Q/58

Device Problems Retraction Problem (1536); Use of Device Problem (1670); Capturing Problem (2891)

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

Event Date 07/18/2023

Event Type  Injury  

Event Description

It was reported that a patient presented with high capture thresholds noted on the right ventricular lead.It was suspected the cardiac tissue of the patient did not conduct the pacing pulse well.During the surgical intervention, the lead helix was unable to retract, resulting in an operation issue.The rv lead was explanted and replaced on (b)(6) 2023.The patient was stable throughout.

Manufacturer Narrative

The reported events were failure to capture, a helix mechanism issue, and operation issue.As received, a complete lead was returned for analysis.The reported event of a helix mechanism issue was confirmed.Visual and x-ray examination of the lead found the inner coil was over torqued at the connector pin region, helix extended and clogged with blood / tissue.After cutting, cleaning, and applying torque directly to the inner coil, the helix could be retracted and extended.The full helix extension length was measured within specification.The reported event of failure to capture was 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: 17455547
• MDR Text Key: 320368675
• Report Number: 2017865-2023-37524
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734502818
• UDI-Public: 05414734502818
• 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: 09/13/2023

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: 7120Q/58
• Device Lot Number: A000128430
• 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: Not provided
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 09/01/2023
• Supplement Dates FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2022
• 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: GALLANT HF; QUARTET LEADS; TENDRIL STS
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male