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

Model Number LDA210Q/65

Device Problems Difficult to Fold, Unfold or Collapse (1254); Retraction Problem (1536); Capturing Problem (2891); Device Dislodged or Dislocated (2923)

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

Event Date 05/03/2023

Event Type  Injury  

Event Description

It was reported that the patient presented in clinic for follow up.Upon review it was noted that the right ventricular lead exhibited high capture threshold.Chest x-ray confirmed that the lead had dislodged.The patient was scheduled for a lead revision.During the lead revision, it was difficult to retract the helix.After finding a good position for the lead, the helix would not extend.The physician decided to explant and implant a new lead.The patient was in stable condition post-procedure.

Manufacturer Narrative

The reported events were lead dislodgement, helix mechanism issue, and high capture threshold.A complete lead was returned in one piece with the helix found partially extended and clogged with blood/ tissue.The reported event of helix mechanism issue was confirmed.X-ray inspection found the inner coil was overtorqued inside the connector region consistent with procedural damage.The cause of helix mechanism issue was due to the helix being clogged with blood/ tissue and overtorque of the inner coil.The reported event of high capture threshold was not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.

• Brand Name: OPTISURE 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: 16956349
• MDR Text Key: 315503662
• Report Number: 2017865-2023-20431
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734507332
• UDI-Public: 05414734507332
• 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
• Report Date: 06/26/2023

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: LDA210Q/65
• Device Catalogue Number: LDA210Q-65
• Device Lot Number: A000118194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/18/2023
• Supplement Dates Manufacturer Received: 05/03/2023; 06/07/2023
• Supplement Dates FDA Received: 05/25/2023; 06/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2021
• 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: 74 YR
• Patient Sex: Male