MAUDE Adverse Event Report: ABBOTT DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD

Model Number 7122Q/58

Device Problems Failure to Capture (1081); Retraction Problem (1536)

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

Event Date 05/08/2023

Event Type  Injury  

Event Description

During a clinic follow-up, an increase in the capture threshold resulting in a loss of capture was observed on the right ventricular (rv) lead.During the revision procedure, the helix of the rv lead was unable to retract.As a result, the rv lead was explanted and replaced to resolve the event.The patient was stable and will continue to be monitored.

Manufacturer Narrative

As received, a complete lead was returned in one piece for analysis with the helix found extended and clogged with blood/tissue.The reported event of a helix mechanism issue was confirmed.Visual and x-ray inspections found the inner coil was over-torqued inside the connector region, which is consistent with procedural damage.After cleaning, the helix was able to retract and extend by applying torque directly to the connector pin.The full helix extension length was measured within specification.The cause of the helix mechanism issue was isolated to the helix being clogged with blood/tissue and an over-torqued inner coil.The reported event of failure to capture was not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: DEFIBRILLATION LEAD
• 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: 16939771
• MDR Text Key: 315307156
• Report Number: 2017865-2023-20089
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503174
• UDI-Public: 05414734503174
• Combination Product (y/n): Y
• Reporter Country Code: SP
• 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: 06/20/2023

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/58
• Device Catalogue Number: 7122Q-58
• Device Lot Number: A000137485
• 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: 05/08/2023
• Initial Date FDA Received: 05/16/2023
• Supplement Dates Manufacturer Received: 06/12/2023
• Supplement Dates FDA Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2023
• 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