MAUDE Adverse Event Report: ABBOTT DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD

Model Number 7122Q/58

Device Problems Retraction Problem (1536); Device Dislodged or Dislocated (2923)

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

Event Date 02/20/2023

Event Type  malfunction  

Event Description

During the initial implant procedure, the right ventricular (rv) lead became dislodged.Repositioning was attempted; however, the helix was unable to retract.The right ventricular lead was explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The reported events were lead dislodgement and a helix retraction failure.As received, only the distal portion of the lead was returned in one piece.The reported event of helix mechanism issue was confirmed.Visual examination of the lead found the helix was retracted and clogged with blood/tissue.After cutting the lead, cleaning and applying torque directly to the inner coil, the helix was able to extend and retract.The measured full helix extension length was within specification.The cause of the reported event of helix mechanism issue was due to the helix clogged with blood/tissue.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• 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: 16418077
• MDR Text Key: 309981896
• Report Number: 2017865-2023-10602
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503174
• UDI-Public: 05414734503174
• Combination Product (y/n): Y
• Reporter Country Code: SP
• 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: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7122Q/58
• Device Catalogue Number: 7122Q-58
• Device Lot Number: A000135540
• 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: 02/21/2023
• Initial Date FDA Received: 02/22/2023
• Supplement Dates Manufacturer Received: 04/03/2023
• Supplement Dates FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2022
• 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