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	Break (1069); Failure to Capture (1081); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the during a routine device change, right ventricular (rv) and right atrial (ra) leads were not capturing.Fraying was noted in both leads on chest x-ray.Both leads were explanted and replaced.The patient is in stable condition.
Event or Problem Description
New information received stated that an evidence of fracture was noted on the rv lead.

• 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: 22749394
• Report Number: 2017865-2025-96624
• Device Sequence Number: 18321843
• Product Code: LWS
• UDI-Device Identifier: 05414734502085
• UDI-Public: (01)05414734502085(10)2734231(17)111130
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 09/26/2025

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: 11/30/2011
• Device Model Number: 7120/60
• Device Lot Number: 2734231
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2008
• 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: CDVRA500Q GALLANT VR_ICD.; DURATA TACHY MRI LEADS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male