MAUDE Adverse Event Report: ABBOTT 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); Failure to Sense (1559); Device Dislodged or Dislocated (2923)

Patient Problem Discomfort (2330)

Event Date 03/07/2024

Event Type  Injury  

Event Description

It was reported that the patient experienced discomfort.During the remote follow up, loss of capture and loss of sensing was noted on the right ventricular (rv) lead due to dislodgment.The device was reprogrammed to disable high voltage therapy and the patient was hospitalized.A revision procedure was performed, however, while repositioning the rv lead, the helix was unable to extend.The rv lead was explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The reported events were lead dislodgement, loss of capture, loss of sensing, and helix mechanism anomaly.As received, a complete lead was returned in one piece.The reported event of helix mechanism anomaly was confirmed.Visual examination of the lead found the helix was retracted and clogged with blood/tissue.X-ray examination of the lead found the inner coil in the connector region was over torqued consistent with procedural damage.After cutting the lead, cleaning the distal portion, and applying torque directly to the inner coil, the helix was able to extend and retract.The measured full helix extension length was within specification.The cause of the reported event of helix mechanism anomaly was due to the over torqued inner coil in the connector region and the helix clogged with blood/tissue.The reported events of loss of capture and loss of sensing were not confirmed.Visual and x-ray examination of the lead did not find any anomalies with the exception of procedural damage.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): 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: 18979182
• MDR Text Key: 338608962
• Report Number: 2017865-2024-36905
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734507332
• UDI-Public: 05414734507332
• Combination Product (y/n): Y
• Reporter Country Code: BE
• 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,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• 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: A000149459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2023
• 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