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

Model Number	LDA210/65
Medical Device Problem Code	Capturing Problem (2891)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Product reference number: 2017865-2025-11106.It was reported that the patient presented at clinic for interrogation of their implantable cardioverter defibrillator (icd).During the evaluation, it was discovered that the icd was exhibiting post-sensed t-wave oversensing and showed signs of crosstalk.An increase in the capture threshold of the right ventricular (rv) lead was noted as well.Programming changes were made.The patient was stable.

• 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: 21191293
• Report Number: 2017865-2025-11107
• Device Sequence Number: 14331946
• Product Code: NVY
• UDI-Device Identifier: 05414734507172
• UDI-Public: (01)05414734507172(10)A000145991(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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: A000145991
• Was Device Available for Evaluation?: No
• 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: 12/31/2024
• Supplement Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2023
• 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: TENDRIL
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 113 KG