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

Model Number	1944/46
Medical Device Problem Codes	Capturing Problem (2891); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for initial implant procedure.The following day, high capture threshold and decreased sensing was noted on the right atrial (ra) lead.An x-ray was performed, and dislodgement was confirmed on the lead.The physician elected to explant and replace the ra lead.The patient condition was stable.
Additional Manufacturer Narrative
The reported events were lead dislodgement, high capture threshold, p-wave amp variation.As received, a complete lead was returned in one piece with all four tines were found to be intact and undamaged.The reported events of high capture thresholds and p-wave amp variation were not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual and x-ray inspections of the lead did not find any anomalies except for procedural damage.

• 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: 22054054
• Report Number: 2017865-2025-53950
• Device Sequence Number: 20131876
• Product Code: NVY
• UDI-Device Identifier: 05414734502313
• UDI-Public: (01)05414734502313(10)P000200491(17)270430
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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
• Report Date (Section B): 06/04/2025

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: P000200491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• 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: 05/02/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ASSURITY MRI.; ISOFLEX OPTIM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female