MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	LDA210Q/52
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had pocket infection and erosion.The entire implantable cardiac defibrillator system was explanted.While explanting the right ventricular lead, the helix exhibited retraction problem.The patient was in stable condition.
Additional Manufacturer Narrative
The reported events were helix mechanism issue.A complete lead was returned in one piece.The reported event of helix mechanism issue was confirmed.Visual examination found the helix was extended and clogged with blood/ tissue.After cleaning, the helix was able to retract and extend by applying torque directly to the connector pin.The full helix extension length was measured within specification.The cause of helix mechanism issue was isolated to the helix being clogged with blood/ tissue.Electrical testing did not find any indication of conductor fractures or internal.A device history record (dhr) review was performed, and review of the sterilization records confirmed normal sterilization cycles for the products.The device met specifications prior to leaving abbott manufacturing facilities.The product was returned, and visual inspection was normal.The cause of infection could not be traced to the device.

• Brand Name: OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 19981339
• Report Number: 2017865-2024-62622
• Device Sequence Number: 18178014
• Product Code: NVY
• UDI-Device Identifier: 05414734507318
• UDI-Public: (01)05414734507318(10)A000126595(17)250531
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 09/18/2024

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: 05/31/2025
• Device Model Number: LDA210Q/52
• Device Lot Number: A000126595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/25/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• 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 Age: 16 YR
• Patient Sex: Female
• Patient Weight: 50 KG