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

Model Number	LDA210/65
Medical Device Problem Codes	Failure to Capture (1081); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 2017865-2025-17062.It was reported that the patient presented in clinic for follow up.Upon review, high capture threshold and loss of capture were noted on the right ventricular (rv) lead.An x-ray was performed, and lack of rv lead slack was noted.The physician elected to explant and replace the rv lead.During the procedure, the implantable cardioverter defibrillator (icd) set screw failed to tighten.The physician elected to explant and replace the icd.The patient condition was stable.
Additional Manufacturer Narrative
The reported events were failure to capture and lead slack issue.The reported event of failure to capture was not confirmed.As received, a complete lead was returned in one piece.Electrical testing did not find any indication of conductor fractures or internal shorts.X-ray examination of the lead did not find any anomalies except for the damage found consistent with procedural damage.Visual inspection of the lead did not find any anomalies.

• 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: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 21596146
• Report Number: 2017865-2025-17064
• Device Sequence Number: 20899462
• Product Code: NVY
• UDI-Device Identifier: 05414734507172
• UDI-Public: (01)05414734507172(10)A000159971(17)270630
• 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: 2025
• Device Explanted Year: 2025
• 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): 03/20/2025

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 Model Number: LDA210/65
• Device Lot Number: A000159971
• 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: 02/24/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• 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: ULTIPACE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 113 KG