MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR; Permanent Defibrillator Electrodes

Model Number	LDA210Q/65
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Under-Sensing (1661)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	08/05/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that alerts of non-sustained right ventricular oversensing episodes recorded ventricular tachycardia/ventricular fibrillation (vt/vf) with under sensing on the implantable cardioverter defibrillator (icd).Further information received notes the patient passed away at the time of the vt/vf episode.It was believed fine (vt/vf) arrhythmia was undersensed and therefore did not meet therapy parameters to deliver shock.No further information was provided.

• Brand Name: OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR
• Common Device Name: Permanent Defibrillator Electrodes
• Manufacturer (Section D): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 50699358
• Report Number: 2017865-2026-19065
• Device Sequence Number: 5915400
• Product Code: NVY
• UDI-Device Identifier: 05414734507332
• UDI-Public: (01)05414734507332(10)A000122219(17)250228
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: 02/28/2025
• Device Model Number: LDA210Q/65
• Device Lot Number: A000122219
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2022
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown