MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR; Permanent defibrillator electrodes

Model Number	LDA220Q/58
Medical Device Problem Code	Failure to Convert Rhythm (1540)
Health Effect - Clinical Codes	Arrhythmia (1721); Unspecified Infection (1930); Discomfort (2330)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record (dhr) review was performed, and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.Review of the sterilization records confirmed normal sterilization cycles for the products.The cause of infection could not be determined.
Event or Problem Description
It was reported that the patient complained of abdominal and chest discomfort and was hospitalized.The patient experienced ventricular fibrillation (vf) that required three rounds of antitachycardia pacing therapy (atp)/(vf) shock therapy.The therapies were unsuccessful and required externally delivered biphasic shock that was successful.The patient was stabilized and eventually transported after echocardiogram results revealed possible vegetation to the rv lead.The patient remained afebrile during this time.Subsequent tests and diagnosis confirmed bacteremia, endocarditis and cardiogenic shock.The system was explanted.The patient received antibiotics and was set to receive a left ventricular assist device (lvad).The patient was subsequently transferred back to the facility¿s intensive care unit in stable condition.

• 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: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 24424495
• Report Number: 2017865-2026-03767
• Device Sequence Number: 10577846
• Product Code: NVY
• UDI-Device Identifier: 05414734507356
• UDI-Public: (01)05414734507356(10)A000081741(17)220531
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2026

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: 05/31/2022
• Device Model Number: LDA220Q/58
• Device Lot Number: A000081741
• 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: 02/04/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American