MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISURE ACTIVE FIXATION; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	LDA210/65
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient presented with dislodgement noted on the patient right ventricular lead.This resulted in over-sensing and inappropriate shock.A rotation issue was noted during the revision process.The lead was explanted and replaced on dec 18, 2024.No adverse patient consequences were reported.
Additional Manufacturer Narrative
The reported events were lead dislodgement, unspecified oversensing, inappropriate shock and helix mechanism issue.As received, a complete lead was returned in one piece with the helix found retracted and clogged with blood.The reported event of helix mechanism issue was confirmed.Unable to perform the helix mechanism / extension length test due to the helix being bent, as received.The cause of the reported event of helix mechanism issue was due to the overtorqued inner coil and the helix being bent and clogged with blood.The reported events of unspecified oversensing and inappropriate shock were not confirmed.Electrical testing did not find any indication of conductor fracture or internal shorts.Visual and x-ray examinations of the lead did not find any anomalies except for procedural damage.

• Brand Name: OPTISURE ACTIVE FIXATION
• Common Device Name: 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: 21096473
• Report Number: 2017865-2025-10460
• Device Sequence Number: 12995574
• Product Code: NVY
• UDI-Device Identifier: 05414734507172
• UDI-Public: (01)05414734507172(10)A000146435(17)260731
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: LDA210/65
• Device Lot Number: A000146435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELLIPSE VR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female