MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM ACTIVE FIXATION; Implantable cardioverter defibrillator (non-CRT)

Model Number	7122/60
Medical Device Problem Code	Failure to Convert Rhythm (1540)
Health Effect - Clinical Code	Arrhythmia (1721)
Type of Reportable Event	Serious Injury
Event or Problem Description
Related reference report number: 2017865-2025-17006.It was reported that failure to convert rhythm was noted on the implantable cardioverter defibrillator (icd) and right ventricular (rv) lead.The physician elected to explant and replace the icd.The patient condition was stable.

• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 21554649
• Report Number: 2017865-2025-17009
• Device Sequence Number: 8179706
• Product Code: LWS
• UDI-Device Identifier: 05414734502146
• UDI-Public: (01)05414734502146(10)3643303(17)150228
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2025

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: 02/28/2015
• Device Model Number: 7122/60
• Device Lot Number: 3643303
• 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: 02/17/2025
• Initial Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2012
• 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: QUARTET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 76 KG