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

Model Number 7121/65

Device Problems Signal Artifact/Noise (1036); Break (1069); Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Low Sensing Threshold (2575)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 12/23/2020

Event Type  Injury  

Manufacturer Narrative

This product is registered as a combination product.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

During an in-clinic follow up, oversensing due to noise which resulted in the administration of inappropriate high voltage therapy was noted on the right ventricular (rv) lead.Moreover, high capture threshold, high pacing impedance, and low sensing threshold were also noted on the rv lead.Technical support was contacted and it was determined that there was also a signal present after the detection of crosstalk and pacing signals which possibly indicates rv loss of capture.It was suspected that the cause of the event was due to lead insulation damage.However, no diagnostic imaging was conducted to confirm the supposition; nor was the alleged cause confirmed during the rv lead revision procedure.The rv lead was capped and replaced to resolve the event.The patient was stable with no consequences.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 11151811
• MDR Text Key: 226233793
• Report Number: 2017865-2021-00946
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 05414734502122
• UDI-Public: 05414734502122
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2011
• Device Model Number: 7121/65
• Device Catalogue Number: 7121-65
• Device Lot Number: 2903242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2008
• 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