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

Model Number 7120/65

Device Problems Break (1069); Low impedance (2285); Charging Problem (2892)

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

Event Date 08/31/2021

Event Type  Injury  

Event Description

During a clinic follow-up, an alert for over current detection (ocd) and a decrease in the defibrillation impedance were noted on the right ventricular (rv) lead.Rv lead damage was suspected, but was unable to be confirmed.The rv lead was capped and replaced to resolve the event.The patient was stable and will continue to be monitored.

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.

• 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: 12476148
• MDR Text Key: 271528655
• Report Number: 2017865-2021-30023
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2014
• Device Model Number: 7120/65
• Device Catalogue Number: 7120-65
• Device Lot Number: 3384238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2011
• 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