MAUDE Adverse Event Report: ABBOTT OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR; Permanent defibrillator electrodes

Model Number LDA210Q/65

Device Problems Intermittent Capture (1080); Difficult to Fold, Unfold or Collapse (1254); Impedance Problem (2950)

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

Event Date 02/26/2024

Event Type  malfunction  

Event Description

It was reported that the intermittent loss of capture and varying pacing impedance were observed on the right ventricular (rv) lead during implant.After multiple lead positioning attempts, the helix was unable to extend.The rv lead was explanted and replaced to resolve the event and the patient was in stable condition.

Manufacturer Narrative

The reported event of failure to extent the helix was confirmed.The reported events of intermittent capture and low lead impedance problem were not confirmed.As received, a complete lead was returned in one piece with the helix retracted and clogged with blood and tissue.A visual and x-ray examination of the helix mechanism revealed no anomalies or distortion of the helix or inner coil that would have contributed to helix issues reported in the field.The cause of the reported event was isolated to the helix being clogged with blood and tissue.Electrical testing was performed and revealed no indication of conductor fractures or internal shorts.No other anomalies were noted.

• Brand Name: OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: Permanent defibrillator electrodes
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18946435
• MDR Text Key: 338184132
• Report Number: 2017865-2024-35490
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734507332
• UDI-Public: 05414734507332
• Combination Product (y/n): Y
• Reporter Country Code: SZ
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LDA210Q/65
• Device Lot Number: A000151975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2024
• 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