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

Model Number	7122Q/52
Medical Device Problem Codes	Signal Artifact/Noise (1036); Break (1069); Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During an in-clinic follow-up, episodes of noise were observed on the right ventricular (rv) lead.Lead damage was suspected but was not confirmed.No intervention was performed.The patient was stable and will continue to be monitored.
Event or Problem Description
Additional information was received that noise resulted in oversensing was observed on the right ventricular (rv) lead.Provocative testing was performed, and noise was not reproduced.Diagnostic imaging was performed during the revision procedure, prior to explant, and lead damage was confirmed.The rv lead was explanted and replaced to resolve event.Rv lead insulation damage was alleged but was not confirmed visually due to procedural damage.The patient was stable.

• 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: 24016305
• Report Number: 2017865-2026-00504
• Device Sequence Number: 9191849
• Product Code: NVY
• UDI-Device Identifier: 05414734503730
• UDI-Public: (01)05414734503730(10)A000105538(17)231231
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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: 12/31/2023
• Device Model Number: 7122Q/52
• Device Lot Number: A000105538
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FORTIFY ASSURA VR ICD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown