MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; Permanent Defibrillator Electrodes

Model Number	7122Q/65
Medical Device Problem Codes	Failure to Advance (2524); Capturing Problem (2891); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During an in-clinic follow-up, a decrease in sensing and increase in capture threshold were observed on the right ventricular (rv) lead.Diagnostic imaging was performed and revealed the rv lead was dislodged.A revision procedure was performed.While attempting to reposition the rv lead, it was not possible to advance a stylet down the lead.The rv lead was explanted and replaced to resolve the event.The patient is stable.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Common Device Name: Permanent Defibrillator Electrodes
• 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: 50884079
• Report Number: 2017865-2026-20055
• Device Sequence Number: 21317132
• Product Code: NVY
• UDI-Device Identifier: 05414734503341
• UDI-Public: (01)05414734503341(10)A000175665(17)280531
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 7122Q/65
• Device Lot Number: A000175665
• 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: 09/07/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Gallant HF device
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown