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

Model Number LDA210Q/65

Device Problem Intermittent Capture (1080)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented remotely via merlin.Net.Upon review, it was found that the patient's right ventricular lead exhibited intermittent capture.No intervention was performed.There were no patient consequences.

Event Description

New information received notes that the patient's right ventricular lead exhibited a recurrence of intermittent capture.Programming changes were made.There were no patient consequences.

• Brand Name: OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: 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: 18411899
• MDR Text Key: 331535544
• Report Number: 2017865-2023-95764
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734507332
• UDI-Public: 05414734507332
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: LDA210Q/65
• Device Lot Number: A000001790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GALLANT; QUARTET; TENDRIL
• Patient Sex: Male
• Patient Weight: 127 KG