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)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information was requested but not yet received.
Event or Problem Description
It was reported that a right atrial (ra) lead was dislodged.The physician decided to explant the ra lead and a new lead was replaced.No patient symptoms were reported.
Additional Manufacturer Narrative
Final analysis performed via visual examination found no malfunctions.
Event or Problem Description
New information received that the atrial lead dislodgement was confirmed visually and associated with no capture.The patient was stable throughout.
Event or Problem Description
New information received that the patient presented to clinic for follow up.
Additional Manufacturer Narrative
Laboratory had re-investigated the analysis of the atrial lead.The analysis conclusion was completed and updated.Based on the latest analysis findings, the reported events were lead dislodgement and failure to capture.As received, a complete lead was returned in two pieces.The reported event of failure to capture was not confirmed.No indication of conductor fractures or internal shorts via electrical testing performed.Visual inspection of the lead found no anomalies except for procedural damage.All tines were intact and undamaged.

• 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: 22477342
• Report Number: 2017865-2025-92891
• Device Sequence Number: 8184130
• Product Code: NVY
• UDI-Device Identifier: 05414734502313
• UDI-Public: (01)05414734502313(10)A000139419(17)260228
• Combination Product (Y/N): Y
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2025

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 Expiration Date: 02/28/2026
• Device Model Number: 1944/46
• Device Lot Number: A000139419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2025
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 07/15/2025; 08/07/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 07/17/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2023
• 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: ASSURITY MRI.; LPA1231/65 ULTIPACE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male