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 Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a remote follow-up, episodes of noise which resulted in myopotential oversensing were observed on the device.Provocative testing was performed and the noise was not reproduced.Technical support was contacted and recommended reprogramming to resolve the event.No intervention has been performed at this time.The patient was stable and will continue to be monitored.

• 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: 50334986
• Report Number: 2017865-2026-17461
• Device Sequence Number: 5713872
• Product Code: LWS
• UDI-Device Identifier: 05414734502092
• UDI-Public: (01)05414734502092(10)3787003(17)150831
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: 7120/65
• Device Lot Number: 3787003
• 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: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2012
• 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
• Patient Sex: Unknown