MAUDE Adverse Event Report: ABBOTT DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	7121Q/65
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Fracture (1260); Failure to Convert Rhythm (1540)
Health Effect - Clinical Codes	Arrhythmia (1721); Discomfort (2330)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experience episodes of ventricular fibrillation (vf) and ventricular tachycardia (vt).The arrhythmias were appropriately detected by the non-abbott device, however, no defibrillation therapy was delivered by the right ventricular (rv) lead.The patient experienced pain, however, the arrythmias self-terminated.The patient was admitted to the hospital and the device was replaced.However, after replacing the device, vf termination was again not successful.A lead fracture was suspected, therefore, the lead was explanted and replaced.The patient was stable.
Additional Manufacturer Narrative
The events of lead fracture, no hv output and inadequate hv output were reported to abbott and confirmed.As received, a complete lead was returned in two pieces.Visual examination of the lead found clavicle crush distal to suture tie impression.X-ray examination found one of the cables and inner coil filars were fracture/ separated.Destructive analysis found one of the superior vena cava cables was fractured/ separated, the inner coil lumen and (polytetrafluoroethylene) ptfe liner were abraded, the inner coil filars were fractured/melted/separated at the clavicle region.The cause of the reported events was due to the fractured/separated one superior vena cava cables and fractured, separated and melted filars of the inner coil consistent with clavicular crush.Subclavian crush is a known potential complication associated with the use of endocardial leads.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Common Device Name: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 23560079
• Report Number: 2017865-2025-1004727
• Device Sequence Number: 15992794
• Product Code: NVY
• UDI-Device Identifier: 05414734503228
• UDI-Public: (01)05414734503228(10)3965493(17)160229
• Combination Product (Y/N): Y
• Initial Reporter Country: BE
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: 02/29/2016
• Device Model Number: 7121Q/65
• Device Lot Number: 3965493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2013
• 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; Hospitalization; Required Intervention
• Patient Sex: Male