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	Retraction Problem (1536); Stretched (1601); Capturing Problem (2891)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented in clinic for routine follow-up.An interrogation found that their right ventricular (rv) and left ventricular (lv) leads exhibited high capture thresholds.During revision procedure, it was noted that the rv lead helix failed to retract and ended up becoming stretched.The rv lead was explanted and replaced.While attempting to implant the replacement lv lead, it was noted that the patient had stenosis, resulting in the replacement lead failing to advance.The attempted replacement lv lead was not implanted, and another lead was implanted successfully on (b)(6) 2026.The patient was stable throughout.

• 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: 50936456
• Report Number: 2017865-2026-20630
• Device Sequence Number: 18541250
• Product Code: NVY
• UDI-Device Identifier: 05414734503341
• UDI-Public: (01)05414734503341(10)A000168132(17)271231
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: A000168132
• 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: 09/14/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female