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 Intermittent Capture (1080); Difficult to Fold, Unfold or Collapse (1254); Retraction Problem (1536); Capturing Problem (2891)

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

Event Type  Injury  

Event Description

It was reported during in clinic follow up that the right ventricular lead exhibited high capture threshold.Lead repositioning was attempted, but unsuccessful as the helix would not retract.The lead was explanted and successfully replaced.The patient was stable and asymptomatic.

Manufacturer Narrative

The reported events were high capture threshold and helix mechanism issue.As received, a complete lead was returned in one piece for analysis.The reported event of helix mechanism issue was confirmed.Visual inspection found the helix to be retracted and clogged with dried blood.X-ray examination found inner coil over-torqued at the connector region consistent with procedural damage.After cutting the lead, cleaning the distal portion of the lead, and applying torque directly to the inner coil, the helix could be extended/retracted, and helix extension length met specification.The cause of helix mechanism issue was isolated to dried blood in the helix region and over-torqued of the inner coil.The reported event of high capture threshold was not confirmed.Electrical testing and x-ray examination did not find any indication of conductor fractures or internal shorts.

Event Description

Additional information received notes that the lead helix failed to extend.

Event Description

Additional information received noted intermittent capture.

• 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: 17613704
• MDR Text Key: 321860245
• Report Number: 2017865-2023-39227
• 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,Followup,Followup
• Report Date: 09/18/2023

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: 7122Q/58
• Device Lot Number: A000142007
• 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: 08/10/2023
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 08/22/2023; 08/22/2023; 09/07/2023
• Supplement Dates FDA Received: 08/28/2023; 08/30/2023; 09/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2023
• 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; TENDRIL
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male