MAUDE Adverse Event Report: ABBOTT DURATA STS OPTIM ACTIVE FIXATION; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 7122/65

Device Problems Failure to Capture (1081); Difficult to Fold, Unfold or Collapse (1254); Retraction Problem (1536); Device Sensing Problem (2917)

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

Event Date 02/16/2024

Event Type  Injury  

Event Description

During follow-up, loss of capture and r wave amplitude variation was observed on the right ventricular (rv) lead.During revision, the helix of the rv lead did not retract or extend.The rv lead was explanted and replaced to resolve the event.The patient was stable and there were no adverse consequences.

Manufacturer Narrative

The reported events were failure to capture, r-wave amplitude variation and helix mechanism issue.As received, a complete lead was returned in one piece.The reported event of helix mechanism issue was confirmed.Visual examination of the lead found the helix was extended and clogged with blood and tissue.X-ray examination of the lead found the inner coil in the connector region was over torqued due to procedural damage.After cutting the lead, cleaning the distal portion of the lead, 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 reported event of helix mechanism issue was isolated to the over-torqued inner coil in the connector region and the helix clogged with blood and tissue.The reported events of failure to capture and r-wave amplitude variation were not confirmed.Visual and x-ray examination of the lead did not find any anomalies with the exception of procedural damage.Electrical testing of the lead did not find any indication of conductor fractures or internal shorts.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 18768211
• MDR Text Key: 336118816
• Report Number: 2017865-2024-33338
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 05414734502153
• UDI-Public: 05414734502153
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 05/07/2024

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: 7122/65
• Device Lot Number: A000140121
• 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: 02/16/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention