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

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

Event Date 05/30/2023

Event Type  Injury  

Event Description

During a clinic follow-up, a loss of capture was observed on the right ventricular (rv) lead.Diagnostic imaging was performed and confirmed a dislodgement of the rv lead.During the revision procedure, the helix of the rv lead was unable to be retracted.As a result, the rv lead was explanted and replaced to resolve the event.The patient was stable and will continue to be monitored.

Manufacturer Narrative

The reported events were dislodgement, failure to capture, and a helix mechanism issue.As received, a complete lead was returned for analysis.The reported event of helix mechanism issue was confirmed.The lead was returned with the helix retracted and clogged with blood/tissue.X-ray inspection found the inner coil over torqued at the connector region, which is consistent with procedural damage.X-ray examination of the helix mechanism found no anomalies or distortion of the helix that would have contributed to the helix mechanism issues reported in the field.The cause of the reported event was isolated to blood/tissue in the helix region and an over torqued the inner coil.The reported event of failure to capture was not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.

• 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: 17276447
• MDR Text Key: 318549034
• Report Number: 2017865-2023-25222
• Device Sequence Number: 1
• Product Code: NVY
• 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
• Report Date: 08/02/2023

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 Catalogue Number: 7122Q-65
• Device Lot Number: A000136538
• 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: 06/19/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 07/27/2023
• Supplement Dates FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2023
• 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