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

Model Number LDA210Q/58

Device Problems Difficult to Fold, Unfold or Collapse (1254); Retraction Problem (1536)

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

Event Date 07/24/2023

Event Type  malfunction  

Event Description

Related manufacturing reference number: 2017865-2023-37198 it was reported during an initial implant procedure that the helix of the right ventricular (rv) lead failed to extend.This was discovered prior to insertion into the body.Additionally, it was noted that the left ventricular (lv) lead became dislodged during the procedure.The dislodgement was discovered using fluoroscopy.The rv and lv lead were not used, and two new leads were successfully implanted on (b)(6) 2023.The patient was stable throughout the procedure.

Event Description

Additional information received via a product return document indicated the physician also had issues with retracting the helix of the right ventricular (rv) lead.

Manufacturer Narrative

The reported event of helix mechanism issue was not confirmed.As received, a complete lead was returned in one piece.Analysis was normal.No anomalies were found.

• 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: 17434691
• MDR Text Key: 320138844
• Report Number: 2017865-2023-37197
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734507325
• UDI-Public: 05414734507325
• 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,Followup,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LDA210Q/58
• Device Lot Number: A000143676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/01/2023
• Supplement Dates Manufacturer Received: 07/24/2023; 08/16/2023
• Supplement Dates FDA Received: 08/14/2023; 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2023
• 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
• Patient Age: 64 YR
• Patient Sex: Female