MAUDE Adverse Event Report: ABBOTT DURATA STS OPTIM ACTIVE FIXATION; DEFIBRILLATION LEAD

Model Number 7120/65

Device Problems Signal Artifact/Noise (1036); Break (1069); Failure to Capture (1081); High impedance (1291); Capturing Problem (2891)

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

Event Date 05/02/2023

Event Type  malfunction  

Event Description

It was reported that during a follow up, increased capture threshold and increased pacing impedance was noted on the right ventricular (rv) lead.Three months prior to the follow up, the patient had received external cardioversion due to atrial fibrillation unrelated to the performance of the implantable cardioverter defibrillator (icd) system.It is unknown if the increase in capture threshold and in crease in pacing impedance was connected to the external cardioversion.Abbott technical support was contacted, however, no intervention has been performed at this time.The patient was in stable condition and will continue to be monitored.

Manufacturer Narrative

Session records were provided for review by technical services.Analysis of the session records indicated that the inadequate capture and high pacing impedance event was sensed by the device.

Event Description

Additional information was received indicating noise and loss of capture were noted on the right ventricular (rv) lead.The physician suspected rv lead damage, however, it is unknown if diagnostic imaging was performed.A revision procedure was performed and the rv lead was capped and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

Event Description

Additional information was received indicating no anomalies of the right ventricular (rv) lead were observed visually nor via diagnostic imaging.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION
• 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: 16991776
• MDR Text Key: 316309252
• Report Number: 2017865-2023-20883
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 05414734502092
• UDI-Public: 05414734502092
• 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,Followup,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2012
• Device Model Number: 7120/65
• Device Catalogue Number: 7120-65
• Device Lot Number: 2922208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2009
• 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
• Treatment: FORTIFY ASSURA VR ICD, US.
• Patient Outcome(s): Required Intervention