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

Model Number 7122Q/58

Device Problems Break (1069); Over-Sensing (1438); Retraction Problem (1536)

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

Event Date 10/16/2023

Event Type  Injury  

Event Description

It was reported that noise resulting in oversensing was noted on the right ventricular (rv) lead.Provocative testing was performed and the noise was able to be reproduced.A revision procedure was performed and the helix of the rv lead was unable to retract.Additionally, rv lead damage was visually observed.The rv lead was explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The reported events were lead damage, oversensing noise, and helix mechanism issue.As received, a complete lead was returned in one piece for analysis.The reported events of lead damage and oversensing were not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual and x-ray inspection of the lead did not find any anomalies except for procedural damage.The reported event of helix mechanism issue was confirmed.The lead was returned with the helix partially extended and clogged with dried blood.X-ray examination found the inner coil over-torqued at the connector region consistent with procedural damage.After cutting the lead, cleaning the distal portion of the lead, and applying torque directly to the inner coil, the helix could be extended/retracted, and helix extension length met specification.The cause of helix mechanism issue was isolated to the helix being clogged with dried blood and overtorqued inner coil.

• 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: 18022048
• MDR Text Key: 326741351
• Report Number: 2017865-2023-50872
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503174
• UDI-Public: 05414734503174
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

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 Lot Number: A000135261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 10/27/2023
• Supplement Dates Manufacturer Received: 11/30/2023
• Supplement Dates FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2022
• 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
• Patient Outcome(s): Required Intervention