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

Model Number	7122/65
Medical Device Problem Codes	Failure to Capture (1081); Device Sensing Problem (2917)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during remote follow-up, the patient's right ventricular (rv) lead exhibited a low r-wave amplitude.During in-clinic testing, loss of capture was also noted on the rv lead.X-ray and computed tomography (ct) imaging revealed that the rv lead had perforated the myocardium and pericardium, with the tip of the lead located in the left pericardial fat.The physician elected to explant the rv lead and replace it with a new one.Following the procedure, a pericardial effusion was observed, and the patient underwent a sternotomy with attempted repair.The patient condition remained stable.
Additional Manufacturer Narrative
A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• 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: 50148127
• Report Number: 2017865-2026-16285
• Device Sequence Number: 18493631
• Product Code: LWS
• UDI-Device Identifier: 05414734502153
• UDI-Public: (01)05414734502153(10)A000179853(17)280930
• 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: 2026
• Device Explanted Year: 2026
• 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): 08/05/2026

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 Model Number: 7122/65
• Device Lot Number: A000179853
• 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: 07/14/2026
• Initial Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2025
• 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; Life Threatening
• Patient Sex: Unknown