MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM ACTIVE FIXATION; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	7120/60
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient received inappropriate shock by the right ventricular (rv) lead.No further information was provided.
Additional Manufacturer Narrative
Correction: report type, new information received indicates event should have been malfunction.There was no indication of a serious injury to the patient.
Event or Problem Description
New information received indicates that the patient presented remotely via merlin.Net.Review of transmission revealed that the implantable cardioverter defibrillator (icd) failed to deliver high voltage therapy due to low, out of range defibrillation impedance.Programming changes were made.The patient was in stable condition.
Event or Problem Description
New information received indicates that the right ventricular (rv) lead was explanted on (b)(6) 2026.
Additional Manufacturer Narrative
The field reports of therapy was aborted for two shocks due to out of range impedance value and low defibrillation impedance were confirmed.As received, a partial lead was returned in two pieces for analysis.Visual inspection found an external insulation abrasion at 7.0 cm to 7.4 cm from the rv connector pin caused by friction to device can breaching the df-1 right ventricular connector leg.One right ventricular etfe cable coating was abraded while the other etfe cable coating was intact at this location.The cause of the reported events was isolated to the exposure of the right ventricular cable conductor at that abrasion location.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 24083093
• Report Number: 2017865-2026-00947
• Device Sequence Number: 17618538
• Product Code: LWS
• UDI-Device Identifier: 05414734502085
• UDI-Public: (01)05414734502085(10)3470105(17)130831
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/18/2026

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: 08/31/2013
• Device Model Number: 7120/60
• Device Lot Number: 3470105
• 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: 12/26/2025
• Supplement Date Received by Manufacturer: 01/15/2026; 04/08/2026; 05/07/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/04/2026; 04/29/2026; 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2010
• 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: TENDRIL STS.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male