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	High impedance (1291)
Health Effect - Clinical Codes	Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	03/12/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that the right ventricular (rv) lead exhibited high voltage (hv) impedance anomaly.On (b)(6)2025, the patient presented to the hospital to extract the right atrial (ra) and rv leads.During the procedure, the superior vena cava (svc) was occluded and the physician was only able to extract that ra lead and a portion of the rv lead.The physician decided to implant an atrial leadless pacemaker (lp).The lp implant was successful, however, after an hour the patient's blood pressure dropped and the patient 'coded.' the patient was treated with ecmo (extracorporeal membrane oxygenation) and later put on life support.It was noted that there was an effusion at the right atrium and inferior vena cava (ivc) junction.The physician suspected that this was caused by lead extraction from the groin.The patient was removed from life support a few days after.
Additional Manufacturer Narrative
A device history record (dhr) review was performed and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• 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: 21764064
• Report Number: 2017865-2025-39163
• Device Sequence Number: 18258621
• Product Code: LWS
• UDI-Device Identifier: 05414734502146
• UDI-Public: (01)05414734502146(10)2664732(17)110630
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• 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): 04/28/2025

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: 06/30/2011
• Device Model Number: 7122/60
• Device Lot Number: 0002664732
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2008
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 54 YR
• Patient Sex: Female