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

Model Number 7122Q/58

Device Problems Failure to Capture (1081); Difficult to Fold, Unfold or Collapse (1254); Retraction Problem (1536)

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

Event Date 06/30/2023

Event Type  Injury  

Event Description

Related manufacturer report number: 2017865-2023-36348 during an in clinic follow up, a loss of capture was observed on the right ventricular (rv) lead.Diagnostic imaging was performed and no anomalies were noted.During the revision procedure, the rv lead was tested on the psa and showed an expected capture, it was reconnected to the device and again a loss of capture was observed.An issue with the device header and connection was suspected.The device was exchanged and while attempting to reposition the rv lead, difficulty positioning and the helix was unable to extend and retract.The rv lead was explanted and replaced to resolve the event.The patient was stable.

Manufacturer Narrative

The reported events were failure to capture and helix mechanism issue.The reported event of helix mechanism issue was confirmed.As received, a complete lead was returned in one piece with the helix found extended and clogged with blood/tissue.X-ray examination of the lead found the inner coil was overtorqued inside the connector region and the helix was stretched consistent with procedural damage.Unable to perform the helix mechanism/extension length test due to stretched helix, as received.The cause of the helix mechanism issue was due to overtorqued inner coil, helix being stretched and clogged with blood/tissue.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: 17366828
• MDR Text Key: 319468971
• Report Number: 2017865-2023-36349
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503174
• UDI-Public: 05414734503174
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 08/22/2023

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/58
• Device Catalogue Number: 7122Q-58
• Device Lot Number: A000135705
• 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: 06/30/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 08/10/2023
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2022
• 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
• Treatment: ELLIPSE DR ICD, US
• Patient Outcome(s): Required Intervention