MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) DURATA STS OPTIM ACTIVE FIXATION; Implantable Cardioverter Defibrillator (Non-Crt)

Model Number	7120/65
Medical Device Problem Codes	Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for in clinic follow-up.Device interrogation revealed that the right ventricular (rv) lead exhibited post-sensed t-wave oversensing (pstwos) resulting in inappropriate shock and inappropriate anti-tachycardia pacing (atp).A chest x-ray was performed, and the physician suspected the right ventricular (rv) lead was interacting with a previously capped lead.Programming changes were performed to resolve the issue.The patient condition was stable.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION
• Common Device Name: Implantable Cardioverter Defibrillator (Non-Crt)
• 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: 50326099
• Report Number: 2017865-2026-17441
• Device Sequence Number: 15852118
• Product Code: LWS
• UDI-Device Identifier: 05414734502092
• UDI-Public: (01)05414734502092(10)S000020033(17)190430
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 08/19/2026

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: 04/30/2019
• Device Model Number: 7120/65
• Device Lot Number: S000020033
• 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: Not provided
• Initial Report FDA Received Date: 08/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2016
• 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: Other
• Patient Sex: Unknown