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

Model Number 7122Q/65

Device Problems Device Contamination with Body Fluid (2317); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/20/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During a follow-up in clinic, a high capture threshold was noted on the right ventricular (rv) lead.X-ray imaging was performed and confirmed dislodgement of the rv lead.During the revision procedure, the helix was unable to rotate and the physician noted some blood in the proximal end of the rv lead and the connector.The rv lead was explanted and replaced.The patient was stable.

Manufacturer Narrative

As received, a complete lead was returned in one piece.Electrical testing did not find any indication of conductor fractures or internal shorts.The reported event of increased threshold and dislodgement was not confirmed.Visual inspection of the lead found the inner coil in the connector region to be over-torqued with blood noted in the connector region.After cleaning the blood off from the helix and applying torque directly to the inner coil, the helix could be extended and retracted.The reported event of a helix rotation issue was confirmed.The cause of the reported event of the helix rotation issue was isolated to the blood and the over-torqued inner coil in the connector region.The reported event of blood contamination in the proximal end of the lead was confirmed; the design of the lead does not seal against blood/body fluids.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: DEFIBRILLATION LEAD
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 9664803
• MDR Text Key: 177588816
• Report Number: 2938836-2020-00847
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503341
• UDI-Public: 05414734503341
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 7122Q/65
• Device Catalogue Number: 7122Q-65
• Device Lot Number: A000073015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2019
• 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; Disability