MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) OPTISURE ACTIVE FIXATION; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	LDA210/65
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the right ventricular lead exhibited oversensing noise.The lead was explanted and replaced.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of oversensing noise was confirmed.As received, a partial lead was returned in three pieces.Visual inspection found clavicular crush damage distal to the suture tie impression.An external insulation abrasion breaching the ring electrode cable lumen with one of the cable coatings also abraded distal to the suture tie impression consistent with friction with another device or feature of the patient¿s anatomy.Destructive analysis revealed that eight filars of inner coil were fractured, consistent with clavicular crush damage.Additionally, abrasion of the inner coil and ptfe liner was observed.Scanning electron microscopy confirmed fractures in all eight filars of the inner coil.The reported events were caused by exposure of the ring electrode cable at the abrasion site and inner coil fractures at the clavicular crush site.

• Brand Name: OPTISURE ACTIVE FIXATION
• 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: 24635851
• Report Number: 2017865-2026-05724
• Device Sequence Number: 13004451
• Product Code: NVY
• UDI-Device Identifier: 05414734507172
• UDI-Public: (01)05414734507172(10)A000093376(17)230131
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• 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): 04/29/2026

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: 01/31/2023
• Device Model Number: LDA210/65
• Device Lot Number: A000093376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2020
• 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: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female