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

Model Number LDA210Q/65

Device Problems Failure to Capture (1081); Failure to Sense (1559); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

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

Event Type  Injury  

Event Description

It was reported that the patient presented in clinic for a follow-up.Upon review, it was discovered that the right ventricular lead exhibited loss of capture and loss of sensing.A chest x-ray was performed, and it noted that the lead was pulled back into the subclavian vein.During the procedure, the lead could be pulled through the suture sleeve only with significant force.The lead was explanted and replaced.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: 19160046
• MDR Text Key: 340790032
• Report Number: 2017865-2024-39313
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734507332
• UDI-Public: (01)05414734507332(10)A000142865(17)260430
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LDA210Q/65
• Device Lot Number: A000142865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/26/2023
• 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; TENDRIL
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male