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); Difficult to Fold, Unfold or Collapse (1254); High impedance (1291); Failure to Sense (1559); Device Dislodged or Dislocated (2923)

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

Event Date 06/24/2023

Event Type  Injury  

Event Description

It was reported that one month post-implant loss of capture, no sensing and high pacing impedance was observed on the right ventricular (rv) lead.An x-ray was performed revealing rv lead dislodgement.During rv lead revision, the helix would not extend.The rv lead was explanted and replaced.There were no adverse health consequences, the patient was stable.

Manufacturer Narrative

The reported event of lead dislodgement, failure to capture, failure to sense, and high pacing impedance was not confirmed, while the reported event of helix mechanism issue was confirmed.As received, a complete lead was returned in one piece with the helix partially extended and clogged blood/tissue.X-ray inspection found the inner coil was over-torqued in the connector region.After cleaning and by applying torque directly to the inner coil, the helix could be extended and retracted.The full helix extension length was measured to be within specification.The cause of the reported event of a helix mechanism issue was isolated to an over-torqued inner coil, consistent with procedural damage and clogged helix.Electrical testing did not find any indication of conductor fractures or internal shorts.

• 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: 17290255
• MDR Text Key: 318740568
• Report Number: 2017865-2023-25428
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734507332
• UDI-Public: 05414734507332
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

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
• Device Operator: Health Professional
• Device Model Number: LDA210Q/65
• Device Catalogue Number: LDA210Q-65
• Device Lot Number: A000137399
• 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: 06/27/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 08/01/2023
• Supplement Dates FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2023
• 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 Outcome(s): Required Intervention