MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ISOFLEX OPTIM LEAD; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	1944/46
Medical Device Problem Codes	Failure to Capture (1081); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right atrial (ra) lead had dislodged and failed to capture.X-ray performed confirmed the lead dislodgement.No intervention was performed.The patient was in stable condition.
Event or Problem Description
New information received indicates that the ra lead was explanted on (b)(6) 2025.The patient was stable throughout the procedure.

• Brand Name: ISOFLEX OPTIM LEAD
• Common Device Name: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 23000578
• Report Number: 2017865-2025-99512
• Device Sequence Number: 18391833
• Product Code: NVY
• UDI-Device Identifier: 05414734502313
• UDI-Public: (01)05414734502313(10)P000200335(17)270430
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: P960030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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 Model Number: 1944/46
• Device Lot Number: P000200335
• 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: 09/03/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2024
• 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
• Patient Sex: Unknown