MAUDE Adverse Event Report: ABBOTT DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 7122Q/65

Device Problems Difficult to Fold, Unfold or Collapse (1254); Failure to Sense (1559); Capturing Problem (2891)

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

Event Date 11/08/2023

Event Type  Injury  

Event Description

During an in clinic follow up, a loss of sensing and increased threshold was observed on the right ventricular (rv) lead.Diagnostic imaging was performed and no anomalies were observed.A revision procedure was performed and when attempting to reposition the rv lead, the helix was unable to be extended.The rv lead was explanted and replaced to resolve the event.The patient was stable.

Manufacturer Narrative

The reported events were helix mechanism issue, loss of sensing and increase thresholds.As received, a complete lead was returned in one piece with helix found partially extended and clogged with dried blood/tissue.The reported event of helix mechanism issue was confirmed.X-ray inspection found overtorque of the inner coil at the connector region consistent with procedural damage.X-ray examination of the helix mechanism found no anomalies or distortion of the helix that would have contributed to helix mechanism issue reported in the field.After cleaning, the helix can be extended and retracted by applying torque directly at the connector pin.The full helix extension length was measured within specification.The cause of the reported event of helix mechanism issue was isolated to blood/tissue in the helix region and overtorqued of the inner coil.The reported events of loss of sensing and increase thresholds were not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual and x-ray inspections of the lead did not find any anomalies except for procedural damage.

• Brand Name: DURATA STS OPTIM 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: 18143880
• MDR Text Key: 328202281
• Report Number: 2017865-2023-52550
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503341
• UDI-Public: 05414734503341
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 12/18/2023

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: 7122Q/65
• Device Lot Number: S000090643
• 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: 11/08/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2023
• 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