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

Model Number 7121/65

Device Problems Failure to Convert Rhythm (1540); Low impedance (2285)

Patient Problem Arrhythmia (1721)

Event Date 04/17/2023

Event Type  Injury  

Event Description

During remote monitoring, the device delivered high voltage therapy in response to ventricular tachycardia/fibrillation, however, the shocks were unable to successfully convert the arrhythmia.When the device delivered the inadequate shocks, low defibrillation impedance was observed on the right ventricular (rv) lead.The patient was later seen in-clinic, and the device was reprogrammed.At a later date, the physician elected to explant and replaced the rv lead.The patient was in stable condition.

Manufacturer Narrative

The reported events of inadequate therapy and low defibrillation impedance were confirmed.As received, a complete lead was returned in one piece.X-ray examination of the lead found one ring electrode conductor cable was separated under the right ventricular shock coil region.An internal short was found between the ring electrode and right ventricular conductor paths.After removing the right ventricle shock coil to examine the condition of the insulation beneath, an internal insulation abrasion was found breaching the ring electrode and right ventricular conductor cable lumens with one ring electrode conductor cable abraded/melted/separated in the abrasion zone.The cause of the reported events was due to the exposure and melted/separated of one ring electrode conductor cable at the abrasion zone beneath the right ventricular shock coil.

• 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: 16824657
• MDR Text Key: 314105650
• Report Number: 2017865-2023-18601
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 05414734502122
• UDI-Public: 05414734502122
• Combination Product (y/n): Y
• Reporter Country Code: LO
• 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: 07/10/2023

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 Expiration Date: 01/31/2012
• Device Model Number: 7121/65
• Device Catalogue Number: 7121-65
• Device Lot Number: 2903430
• 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: 04/20/2023
• Initial Date FDA Received: 04/27/2023
• Supplement Dates Manufacturer Received: 04/20/2023
• Supplement Dates FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2009
• 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
• Patient Outcome(s): Required Intervention