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

Model Number 7122Q/65

Device Problems Difficult to Fold, Unfold or Collapse (1254); Retraction Problem (1536); Capturing Problem (2891)

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

Event Date 04/02/2024

Event Type  Injury  

Event Description

It was reported that increased capture threshold was observed on the right ventricular (rv) lead.During revision, repositioning was attempted but the helix of the rv lead failed to retract.The rv lead was explanted and replaced to resolve the event.The patient was stable and there were no adverse consequences.

Event Description

It was reported that increased capture threshold was observed on the right ventricular (rv) lead.During revision, repositioning was attempted but the helix of the rv lead failed to extend.The rv lead was explanted and replaced to resolve the event.The patient was stable and there were no adverse consequences.

• 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: 19072555
• MDR Text Key: 339732574
• Report Number: 2017865-2024-38044
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503341
• UDI-Public: (01)05414734503341(10)A000152205(17)261231
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2024

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 Model Number: 7122Q/65
• Device Lot Number: A000152205
• 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: 04/02/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: Not provided; 05/02/2024
• Supplement Dates FDA Received: 04/19/2024; 05/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/12/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention