MAUDE Adverse Event Report: ABBOTT DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 7122Q/65

Device Problems Failure to Capture (1081); High impedance (1291); Difficult to Insert (1316); Low impedance (2285); Device Sensing Problem (2917)

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

Event Date 03/05/2024

Event Type  malfunction  

Event Description

It was reported that during a device replacement procedure, loss of capture, reduced sensing, and high pacing impedance were noted on the right ventricular (rv) lead after connecting to the new device.The rv lead was connected to another device and loss of capture, reduced sensing, and high pacing impedance were again noted.The physician suspected incomplete insertion of the rv lead into the header.Additional connection attempts were made and the rv lead was able to be successfully connected and remains implanted, in use.The patient was in stable condition.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 18994275
• MDR Text Key: 338874324
• Report Number: 2017865-2024-37140
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503341
• UDI-Public: 05414734503341
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: 7122Q/65
• Device Lot Number: 3662196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2012
• 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